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Post by actcfan on Nov 23, 2015 19:28:08 GMT
As I stated prior, I think this statement is anything but clear. Some choose to interpret the reference to pre-clinical as related to RPE, so do not. I don't for the reasons I already posted - HMC and MSC are also 'potential therapeutic products' and RPE risks were already covered in the prior statement (i.e. bullet point). The reason why I tend to disagree is that if you read the entire 14D it is all about the RPE program. There is no talk about MSC or HMC in the entire filing. The handful of times that non-RPE pre-clinical programs are mentioned they don't really have any relevance in this deal. It's not even really on the map. The whole thing is focused around the value of the RPE program. Suddenly mentioning the need for "additional extensive" testing on their pre-clinical programs as being a concern going forward just doesn't make sense to me in the totality of this filing. Anyway, we'll probably have to agree to disagree so I'll leave it at that. Not sure we are reading and interpreting this document the same Jham, as over and over again the BOD is evaluating the performance and status of the R&D programs as they review these proposals. To me that gives them direct relevance. From the 8/31/2015 BOD meeting:On August 31, 2015, the Board held a meeting to further evaluate the Initial Proposal. Also in attendance at the meeting were members of Ocata management and representatives of Goodwin Procter. Representatives of Goodwin Procter reviewed with the Board its fiduciary duties in connection with considering a potential sale of Ocata. At the invitation of the Board, Jefferies then joined the meeting to discuss with the Board certain financial aspects of the Initial Proposal. In its consideration of the Initial Proposal, the Board reviewed Ocata’s short- and long-term business strategies and prospects as a standalone business, the competitive landscape and market trends in the industry, and the challenges confronting Ocata in achieving its strategic objectives, including Ocata’s significant capital funding needs for its ongoing clinical trials, the challenges in securing advantageous licensing partnerships to contribute to the funding of Ocata’s development operations, the performance and status of Ocata’s research and development programs, as well as the significant cost levels required to continue and maintain these programs and the long development period and inherent uncertainty in the development of the Company’s treatment programs, and in obtaining regulatory approvals for such treatments. In light of this discussion, the directors concluded that they should review the Initial Proposal in the context of Ocata’s standalone plan and possible interest from other potential strategic partners. While the Board determined to further evaluate the Initial Proposal, it concluded as a preliminary matter that Jefferies should contact Citi, and in an attempt to seek an improved price from Astellas, indicate that the Board believed that the Initial Proposal undervalued Ocata. The Board also concluded that it was not appropriate at this time to consider or respond to Astellas’ request to engage in exclusive negotiations.
From the 10/25/2015 BOD meeting:
On October 25, 2015, the Board held a meeting to discuss, among other things, the October 19 Proposal, the solicitation of selected potential strategic acquirers, and management’s standalone plan. In attendance at the meeting were members of Ocata management and representatives of Jefferies and Goodwin Procter. Representatives of Goodwin Procter reviewed with the Board its fiduciary duties in connection with considering a potential sale of Ocata. Jefferies discussed with the Board the mergers and acquisitions landscape generally and within Ocata’s industry, the status of discussions with Astellas and the other potential acquirers, including the fact that none of the parties contacted indicated interest in a potential strategic transaction with Ocata. Jefferies also discussed certain financial aspects of the October 19 Proposal.
At the meeting, members of Ocata management informed the Board that Ocata was anticipating a potential delay of approximately four months in randomizing patients in its AMD Phase 2 study as a result of a higher than anticipated screen failure rate among enrolled patients against the strict entry criteria for the study. It was anticipated that there could be a corresponding delay in the Company’s ability to access capital, which previously was expected to follow delivery of interim results of the clinical study. It was not anticipated that this screening delay would delay the overall study timetable. In light of this development, the Board requested that management prepare a plan for a reduction in near-term operating expenses to account for this potential delay.
The Board considered Astellas’ increased purchase price of $8.40 per Share in cash in light of the management standalone plan and risks and opportunities facing the business. In its consideration of the October 19 Proposal, the Board continued to review Ocata’s short- and long-term business strategies, the competitive landscape and market trends in the industry, and the challenges confronting Ocata in achieving its strategic objectives, including Ocata’s capital funding requirement for its ongoing clinical trials, the challenges in securing advantageous licensing partnerships to contribute to the funding of Ocata’s development operations, the performance and status of Ocata’s research and development programs, as well as the significant cost levels required to continue and maintain these programs and the long development period and inherent uncertainty in the development of the Company’s treatment programs, including obtaining regulatory approvals for such treatments. Ocata’s management discussed with the Board the potential benefits to Ocata’s stockholders of an acquisition of Ocata, including by providing immediate liquidity to stockholders while eliminating their exposure to the risks in Ocata’s standalone plan.
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Post by tacomafunk on Nov 23, 2015 19:31:02 GMT
my 2 cents:
PW & BOD must have known there would be shareholder dissatisfaction with this deal. If there are truly licensure issues, then perhaps this is really in the best interest of all shareholders. But then it would make sense for them to explicitly tell shareholders this since it would make them more likely to tender their shares.
In my opinion, either there are no licensure issues, or if there are, then PW must have thought that admitting this could strengthen lawsuits brought against them, even though admitting licensure issues would make more shareholders more likely to tender their shares.
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Post by greatceasarsghost on Nov 23, 2015 19:36:53 GMT
my 2 cents: PW & BOD must have known there would be shareholder dissatisfaction with this deal. If there are truly licensure issues, then perhaps this is really in the best interest of all shareholders. But then it would make sense for them to explicitly tell shareholders this since it would make them more likely to tender their shares. In my opinion, either there are no licensure issues, or if there are, then PW must have thought that admitting this could strengthen lawsuits brought against them, even though admitting licensure issues would make more shareholders more likely to tender their shares. Sadly I think even if Wotton was 100% transparent, there would be those who still wouldn't tender because they think something is being held back. They've been conditioned to think that this stock would make them/us millionaires. That's hard to break!! |
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Post by harlem on Nov 23, 2015 20:12:23 GMT
wonton said jv this year and start of p2 while he was in the middle of selling the company and asking for more free shares to distribute internally not to mention selling shares and warrants (diluting small shareholders) while at the the table with a$$tellas. These are facts about wonton/mgt that would lead anyone to think of mgt as untrustworthy to say the least.
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Post by JHam on Nov 24, 2015 2:39:38 GMT
The reason why I tend to disagree is that if you read the entire 14D it is all about the RPE program. There is no talk about MSC or HMC in the entire filing. The handful of times that non-RPE pre-clinical programs are mentioned they don't really have any relevance in this deal. It's not even really on the map. The whole thing is focused around the value of the RPE program. Suddenly mentioning the need for "additional extensive" testing on their pre-clinical programs as being a concern going forward just doesn't make sense to me in the totality of this filing. Anyway, we'll probably have to agree to disagree so I'll leave it at that. Not sure we are reading and interpreting this document the same Jham, as over and over again the BOD is evaluating the performance and status of the R&D programs as they review these proposals. To me that gives them direct relevance. From the 8/31/2015 BOD meeting:On August 31, 2015, the Board held a meeting to further evaluate the Initial Proposal. Also in attendance at the meeting were members of Ocata management and representatives of Goodwin Procter. Representatives of Goodwin Procter reviewed with the Board its fiduciary duties in connection with considering a potential sale of Ocata. At the invitation of the Board, Jefferies then joined the meeting to discuss with the Board certain financial aspects of the Initial Proposal. In its consideration of the Initial Proposal, the Board reviewed Ocata’s short- and long-term business strategies and prospects as a standalone business, the competitive landscape and market trends in the industry, and the challenges confronting Ocata in achieving its strategic objectives, including Ocata’s significant capital funding needs for its ongoing clinical trials, the challenges in securing advantageous licensing partnerships to contribute to the funding of Ocata’s development operations, the performance and status of Ocata’s research and development programs, as well as the significant cost levels required to continue and maintain these programs and the long development period and inherent uncertainty in the development of the Company’s treatment programs, and in obtaining regulatory approvals for such treatments. In light of this discussion, the directors concluded that they should review the Initial Proposal in the context of Ocata’s standalone plan and possible interest from other potential strategic partners. While the Board determined to further evaluate the Initial Proposal, it concluded as a preliminary matter that Jefferies should contact Citi, and in an attempt to seek an improved price from Astellas, indicate that the Board believed that the Initial Proposal undervalued Ocata. The Board also concluded that it was not appropriate at this time to consider or respond to Astellas’ request to engage in exclusive negotiations.
From the 10/25/2015 BOD meeting:
On October 25, 2015, the Board held a meeting to discuss, among other things, the October 19 Proposal, the solicitation of selected potential strategic acquirers, and management’s standalone plan. In attendance at the meeting were members of Ocata management and representatives of Jefferies and Goodwin Procter. Representatives of Goodwin Procter reviewed with the Board its fiduciary duties in connection with considering a potential sale of Ocata. Jefferies discussed with the Board the mergers and acquisitions landscape generally and within Ocata’s industry, the status of discussions with Astellas and the other potential acquirers, including the fact that none of the parties contacted indicated interest in a potential strategic transaction with Ocata. Jefferies also discussed certain financial aspects of the October 19 Proposal.
At the meeting, members of Ocata management informed the Board that Ocata was anticipating a potential delay of approximately four months in randomizing patients in its AMD Phase 2 study as a result of a higher than anticipated screen failure rate among enrolled patients against the strict entry criteria for the study. It was anticipated that there could be a corresponding delay in the Company’s ability to access capital, which previously was expected to follow delivery of interim results of the clinical study. It was not anticipated that this screening delay would delay the overall study timetable. In light of this development, the Board requested that management prepare a plan for a reduction in near-term operating expenses to account for this potential delay.
The Board considered Astellas’ increased purchase price of $8.40 per Share in cash in light of the management standalone plan and risks and opportunities facing the business. In its consideration of the October 19 Proposal, the Board continued to review Ocata’s short- and long-term business strategies, the competitive landscape and market trends in the industry, and the challenges confronting Ocata in achieving its strategic objectives, including Ocata’s capital funding requirement for its ongoing clinical trials, the challenges in securing advantageous licensing partnerships to contribute to the funding of Ocata’s development operations, the performance and status of Ocata’s research and development programs, as well as the significant cost levels required to continue and maintain these programs and the long development period and inherent uncertainty in the development of the Company’s treatment programs, including obtaining regulatory approvals for such treatments. Ocata’s management discussed with the Board the potential benefits to Ocata’s stockholders of an acquisition of Ocata, including by providing immediate liquidity to stockholders while eliminating their exposure to the risks in Ocata’s standalone plan.
Yes I read those. There is even a paragraph explaining how both CEO's met in Boston to discuss the non-RPE programs. That is not what I am talking about. What I am saying is there is never any talk about the future regulatory approval of any of the pre-clinical programs that I have found. Just that they have some other non-RPE pre-clinical programs in development. It is kind of out of left field (imo) for them to be referring to *additional extensive* testing on non-RPE programs. Especially since the RPE program is discussed in such detail throughout the 14D and even mentioned in the same sentence in the snippet in question. Given the Company’s focus on its RPE program and lack of capital to pursue both the RPE program and preclinical programs to commercialization, the Ocata Projections were prepared assuming that the RPE program was the only source of revenue. Therefore, estimates of clinical development expenses associated with other Ocata preclinical assets were not included in the Ocata Projections. Certain assumptions and estimates made by Ocata management in support of the Ocata Projections are set forth below...Here is how I read the snippet in question :...noting in particular the costs and risks associated with developing, testing, manufacturing and commercializing the clinical stage products in Ocata’s RPE program, that potential therapeutic products would require additional extensive pre-clinical and clinical testing prior to any possible regulatory approval in the United States and other countries and may additionally require post-authorization outcome studies |
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Post by JHam on Nov 24, 2015 3:18:12 GMT
Just to recap and for reference, here is what we learned about potential licensure issues from Michael West in Bullard's SA interview: seekingalpha.com/article/2688285As Dr. West stated, "When putting cells in the Central Nervous System, you really need to document the prion. There's no diagnostic test for prion. The only way to know if these cells are carrying these transmissibles; spongiform encephalopathy, which is a devastating disorder (is through documentation of the donor). Believe it or not, the FDA allows clinical trials on products that cannot document prion status but to license the product you have to have documentation of prion status."
This concern by Dr. West is well founded. There is currently a disconnect within the FDA guidelines that allow for initiation of stem cell trials without the cells being adequately documented. However, licensure requires certain documentation of the donors, which many stem cell companies don't possess.
The issue has been well documented as referenced in the Cell Stem Cell article, Differing Standards for the NIH Stem Cell Registry and FDA Approval Render Most Federally Funded hESC Lines Unsuitable for Clinical Use, which included the following passage,
For basic hESC research, it does not matter that NIH Registry hESC lines may come from unscreened embryo donors. However, for therapeutics development, it matters a great deal. Problematically, the vast majority of translational research projects now being conducted in federally funded institutions utilize NIH Registry hESC lines; again, these are the only lines for which they can get federal funding. The absence of embryo donor testing information for these lines means that they would not meet the FDA's requirements for a therapeutic product unless the FDA made an exception to their guidance. However, it is entirely unclear whether the FDA would make such an exception, as revealed at a joint NIH/FDA public meeting in March 2011, "Pluripotent Stem Cells in Translation: Early Decisions." The issue remains unresolved.
Even more relevant was this warning,
But without definitive proof of donor eligibility, private companies and investors may be unlikely to agree to get involved in commercialization of a currently FDA-ineligible line. Given the enormous commitment in resources for product development, it is essential for developers to know early on whether moving a particular cell line forward will be worth the investment.
At some point, the FDA may develop procedures that address this issue but none exist currently. And, the prospects of prion from undocumented cells should encourage the FDA to move very cautiously. BioTime is somewhat late to the game but beginning trials with a xeno-free (no animal products), well documented stem cell product offers a clear advantage.
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Post by i(n) sight on Nov 24, 2015 7:08:03 GMT
Just to recap and for reference, here is what we learned about potential licensure issues from Michael West in Bullard's SA interview: seekingalpha.com/article/2688285As Dr. West stated, "When putting cells in the Central Nervous System, you really need to document the prion. There's no diagnostic test for prion. The only way to know if these cells are carrying these transmissibles; spongiform encephalopathy, which is a devastating disorder (is through documentation of the donor). Believe it or not, the FDA allows clinical trials on products that cannot document prion status but to license the product you have to have documentation of prion status."
This concern by Dr. West is well founded. There is currently a disconnect within the FDA guidelines that allow for initiation of stem cell trials without the cells being adequately documented. However, licensure requires certain documentation of the donors, which many stem cell companies don't possess.
The issue has been well documented as referenced in the Cell Stem Cell article, Differing Standards for the NIH Stem Cell Registry and FDA Approval Render Most Federally Funded hESC Lines Unsuitable for Clinical Use, which included the following passage,
For basic hESC research, it does not matter that NIH Registry hESC lines may come from unscreened embryo donors. However, for therapeutics development, it matters a great deal. Problematically, the vast majority of translational research projects now being conducted in federally funded institutions utilize NIH Registry hESC lines; again, these are the only lines for which they can get federal funding. The absence of embryo donor testing information for these lines means that they would not meet the FDA's requirements for a therapeutic product unless the FDA made an exception to their guidance. However, it is entirely unclear whether the FDA would make such an exception, as revealed at a joint NIH/FDA public meeting in March 2011, "Pluripotent Stem Cells in Translation: Early Decisions." The issue remains unresolved.
Even more relevant was this warning,
But without definitive proof of donor eligibility, private companies and investors may be unlikely to agree to get involved in commercialization of a currently FDA-ineligible line. Given the enormous commitment in resources for product development, it is essential for developers to know early on whether moving a particular cell line forward will be worth the investment.
At some point, the FDA may develop procedures that address this issue but none exist currently. And, the prospects of prion from undocumented cells should encourage the FDA to move very cautiously. BioTime is somewhat late to the game but beginning trials with a xeno-free (no animal products), well documented stem cell product offers a clear advantage.
I have been pondering this licensure issue for a while. Given the bolded above, I would say there is no licensure issue as that would be a material event IMO. Wait. There is however a potential licensure issue that ultimately blocks commercialization given the above bolded. Potential issue is not a material event IMO; FDA hasn't said no; a technicality. Ocata does not have the resources to start over with a new line. Is the RPE the lowest hanging fruit given the extensive IP when Astellas checked things out? Patti notes in a prior post in this thread from a 2014 shareholder meeting:
Q: MAO9 lines not xeno free matter with agencies, can commercialize[.]
A: MA09 not xeno free but not prohibiting us, long as we’re meeting safety margins and seeing results we can move forward. Data trumps everything. Safety data we have gives us a lot of confidence.
I don’t think the answer above clearly answers the question. Is someone being a wordsmith? Or should retail shareholders be justifiably paranoid in dissecting every word from management, again; the new normal given the turn of events. Ok, so nothing to prohibit them moving forward but that is quite different from getting to licensure and commercialization. The line is eligible for research purposes, but possibly not commercialization. So, what to do? Japan has suffered National disgrace with the STAP and other stem cell crap. Some really rushed trials with little testing if you care to check it out. A matter of National pride and saving face now. And less regulations vs USA. Plenty of time and money for Astellas to re-do the line for the USA end of things. For Japan, if the science works, and I think it does, they will make plenty without the USA in the interim, then try for approval here, and then make even more unless blocked. And plenty of monies to do the rest as of the IND's as well. Culturally, the acquisition makes sense. And Ocata management makes out well and on to the next thing. So why doesn’t a USA BP make an offer? They may now, or they may prefer that it all go away as pills seem to be the thing to do and buy out Astellas later if necessary and possible. Well, have a Happy Thanksgiving everyone. |
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Post by JHam on Nov 24, 2015 7:42:10 GMT
Just to recap and for reference, here is what we learned about potential licensure issues from Michael West in Bullard's SA interview: seekingalpha.com/article/2688285As Dr. West stated, "When putting cells in the Central Nervous System, you really need to document the prion. There's no diagnostic test for prion. The only way to know if these cells are carrying these transmissibles; spongiform encephalopathy, which is a devastating disorder (is through documentation of the donor). Believe it or not, the FDA allows clinical trials on products that cannot document prion status but to license the product you have to have documentation of prion status."
This concern by Dr. West is well founded. There is currently a disconnect within the FDA guidelines that allow for initiation of stem cell trials without the cells being adequately documented. However, licensure requires certain documentation of the donors, which many stem cell companies don't possess.
The issue has been well documented as referenced in the Cell Stem Cell article, Differing Standards for the NIH Stem Cell Registry and FDA Approval Render Most Federally Funded hESC Lines Unsuitable for Clinical Use, which included the following passage,
For basic hESC research, it does not matter that NIH Registry hESC lines may come from unscreened embryo donors. However, for therapeutics development, it matters a great deal. Problematically, the vast majority of translational research projects now being conducted in federally funded institutions utilize NIH Registry hESC lines; again, these are the only lines for which they can get federal funding. The absence of embryo donor testing information for these lines means that they would not meet the FDA's requirements for a therapeutic product unless the FDA made an exception to their guidance. However, it is entirely unclear whether the FDA would make such an exception, as revealed at a joint NIH/FDA public meeting in March 2011, "Pluripotent Stem Cells in Translation: Early Decisions." The issue remains unresolved.
Even more relevant was this warning,
But without definitive proof of donor eligibility, private companies and investors may be unlikely to agree to get involved in commercialization of a currently FDA-ineligible line. Given the enormous commitment in resources for product development, it is essential for developers to know early on whether moving a particular cell line forward will be worth the investment.
At some point, the FDA may develop procedures that address this issue but none exist currently. And, the prospects of prion from undocumented cells should encourage the FDA to move very cautiously. BioTime is somewhat late to the game but beginning trials with a xeno-free (no animal products), well documented stem cell product offers a clear advantage.
I have been pondering this licensure issue for a while. Given the bolded above, I would say there is no licensure issue as that would be a material event IMO. Wait. There is however a potential licensure issue that ultimately blocks commercialization given the above bolded. Potential issue is not a material event IMO; FDA hasn't said no; a technicality. Ocata does not have the resources to start over with a new line. Is the RPE the lowest hanging fruit given the extensive IP when Astellas checked things out? Patti notes in a prior post in this thread from a 2014 shareholder meeting:
Q: MAO9 lines not xeno free matter with agencies, can commercialize[.]
A: MA09 not xeno free but not prohibiting us, long as we’re meeting safety margins and seeing results we can move forward. Data trumps everything. Safety data we have gives us a lot of confidence.
I don’t think the answer above clearly answers the question. Is someone being a wordsmith? Or should retail shareholders be justifiably paranoid in dissecting every word from management, again; the new normal given the turn of events. Ok, so nothing to prohibit them moving forward but that is quite different from getting to licensure and commercialization. The line is eligible for research purposes, but possibly not commercialization. So, what to do? Japan has suffered National disgrace with the STAP and other stem cell crap. Some really rushed trials with little testing if you care to check it out. A matter of National pride and saving face now. And less regulations vs USA. Plenty of time and money for Astellas to re-do the line for the USA end of things. For Japan, if the science works, and I think it does, they will make plenty without the USA in the interim, then try for approval here, and then make even more unless blocked. And plenty of monies to do the rest as of the IND's as well. Culturally, the acquisition makes sense. And Ocata management makes out well and on to the next thing. So why doesn’t a USA BP make an offer? They may now, or they may prefer that it all go away as pills seem to be the thing to do and buy out Astellas later if necessary and possible. Well, have a Happy Thanksgiving everyone. Nice post insight. I think you have spelled it out nicely. The "potential" issue with licensure is the issue. I also do not think the FDA has said no to OCAT, but I think there is a good chance OCAT knows the answer. I do think words were played with and that's why OCAT has never had to report it as a material event. Whether Japan is careless in their approach to speed up getting therapies to the bed side remains to be seen. The new legislation there allows for therapies to be approved on a conditional basis as long as they have shown probable efficacy and have a good safety record in a clinical trial. That is the reason why this happened with a Japanese pharma in my opinion and why I don't anticipate interest from any US/EU based BPs. Hopefully I am wrong on that for those who were hoping for a better return. One last point regarding the paragraph having to do *additional* extensive pre-clinical work. Even if that paragraph is referring to other non-RPE programs, wouldn't that still suggest that there is an issue with licensure? What would be the reason why they would need to do additional extensive pre-clinical trials on the MSC or any other program again? Maybe that's why after boasting to have the "gold standard" of stem cells during the Caldwell years, they gradually started talking about doing future programs with iPSCs. Maybe it's why they licensed the iPSC line from Allele. www.businesswire.com/news/home/20150324005709/en/Ocata-Therapeutics-Licenses-Induced-Pluripotent-Stem-Cell |
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Post by actcfan on Nov 24, 2015 15:11:49 GMT
They call out the "RPE program" often in this document including in this pivotal sentence we are discussing, so not sure why they would refer to "potential therapeutic products would require additional extensive pre-clinical" - Why not just say the RPE program "would require.."? Think we will just have to agree to disagree Jham.
noting in particular the costs and risks associated with developing, testing, manufacturing and commercializing the clinical stage products in Ocata’s RPE program, that potential therapeutic products would require additional extensive pre-clinical and clinical testing prior to any possible regulatory approval in the United States and other countries and may additionally require post-authorization outcome studies
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Post by JHam on Nov 24, 2015 16:56:35 GMT
They call out the "RPE program" often in this document including in this pivotal sentence we are discussing, so not sure why they would refer to " potential therapeutic products would require additional extensive pre-clinical" - Why not just say the RPE program "would require.."? Think we will just have to agree to disagree Jham. noting in particular the costs and risks associated with developing, testing, manufacturing and commercializing the clinical stage products in Ocata’s RPE program, that potential therapeutic products would require additional extensive pre-clinical and clinical testing prior to any possible regulatory approval in the United States and other countries and may additionally require post-authorization outcome studiesAt the risk of being really annoying (too late) my answer is that they did say it: "...noting in particular the costs and risks associated with developing, testing, manufacturing and commercializing the clinical stage products in Ocata’s RPE program, that potential therapeutic products would require additional extensive pre-clinical and clinical testing prior to any possible regulatory approval in the United States and other countries and may additionally require post-authorization outcome studies"No doubt is a poorly worded sentence, but I read it as the "potential therapeutic products", being products related to the RPE program. That is why they would require "additional extensive pre-clinical and clinical testing". But again, if they are referring to having to do additional testing on pre-clinical non-RPE programs, then it still suggests licensure issues, imo. Anyway, I'll leave it at that  |
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Post by jckrdu on Nov 24, 2015 17:08:14 GMT
They call out the "RPE program" often in this document including in this pivotal sentence we are discussing, so not sure why they would refer to " potential therapeutic products would require additional extensive pre-clinical" - Why not just say the RPE program "would require.."? Think we will just have to agree to disagree Jham. noting in particular the costs and risks associated with developing, testing, manufacturing and commercializing the clinical stage products in Ocata’s RPE program, that potential therapeutic products would require additional extensive pre-clinical and clinical testing prior to any possible regulatory approval in the United States and other countries and may additionally require post-authorization outcome studiesAt the risk of being really annoying (too late) my answer is that they did say it: "...noting in particular the costs and risks associated with developing, testing, manufacturing and commercializing the clinical stage products in Ocata’s RPE program, that potential therapeutic products would require additional extensive pre-clinical and clinical testing prior to any possible regulatory approval in the United States and other countries and may additionally require post-authorization outcome studies"No doubt is a poorly worded sentence, but I read it as the "potential therapeutic products", being products related to the RPE program. That is why they would require "additional extensive pre-clinical and clinical testing". But again, if they are referring to having to do additional testing on pre-clinical non-RPE programs, then it still suggests licensure issues, imo.
Anyway, I'll leave it at that I'm with Actc_Fan's interpretation on this one JHam.
Agree its a poorly worded sentence, but I read it essentially as a list of separate risks separated by commas and use of the work "that" preceding the risks.
On the bolded above, I don't think it definitively suggests licensure issues. I think additional pre-clinical testing would be needed on everything with the exception of SMD and Dry AMD, as OCAT did disclose that the next IND was still 2 years away... which means they still had pre-clinical testing to do, most likely using the IPS lines licensed from Allere. Did they license those lines from Allere because of licensure issues, or because they see IPS as the future? We'll probably never know.
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Post by CM kipper007 on Nov 24, 2015 18:07:56 GMT
At the risk of being really annoying (too late) my answer is that they did say it: "...noting in particular the costs and risks associated with developing, testing, manufacturing and commercializing the clinical stage products in Ocata’s RPE program, that potential therapeutic products would require additional extensive pre-clinical and clinical testing prior to any possible regulatory approval in the United States and other countries and may additionally require post-authorization outcome studies"No doubt is a poorly worded sentence, but I read it as the "potential therapeutic products", being products related to the RPE program. That is why they would require "additional extensive pre-clinical and clinical testing". But again, if they are referring to having to do additional testing on pre-clinical non-RPE programs, then it still suggests licensure issues, imo.
Anyway, I'll leave it at that I'm with Actc_Fan's interpretation on this one JHam.
Agree its a poorly worded sentence, but I read it essentially as a list of separate risks separated by commas and use of the work "that" preceding the risks.
On the bolded above, I don't think it definitively suggests licensure issues. I think additional pre-clinical testing would be needed on everything with the exception of SMD and Dry AMD, as OCAT did disclose that the next IND was still 2 years away... which means they still had pre-clinical testing to do, most likely using the IPS lines licensed from Allere. Did they license those lines from Allere because of licensure issues, or because they see IPS as the future? We'll probably never know.
I'm curious to know if the MMD trial has something to do with the testing. I can really see Astellas getting hold of the technology if say for example, they can skip phase 1 in Japan for MMD. This would also fit some of the wording used. Comparing timeliness with the US and Japan. |
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