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Post by Keybridge - Cult Member 003 on Nov 22, 2014 21:35:06 GMT
Management has tuned over since Rabin made those remarks.
Wotton and his team have commented that the MA09 line is sufficient to commercialize. Wotton's comments prime those of Rabin, if for no other reason that Wotton's statements are current based on the company's discussions with the FDA.
Might the company bridge to a NED because it makes business sense, I tend to believe they will at some point - they certainly know how derive RRE cells from a NED line in the same way they know how to derive RPE cells from the existing MA09 line. Seems to be a non issue.
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agendaman
New Member
Wherever Agenda Lurks, AgendaMan will Uncover it!
Posts: 10
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Post by agendaman on Nov 22, 2014 21:35:57 GMT
University College London , isn't that where Prof. P. Coffey is working out of? hmm? Now, this well connected in the Reg. Med. field Chris Mason who is also a senior partner at Proteus Venture, might have an agenda? Disclosure; I'm not a fan of Dr. West. All fishy smelly..imo. Go OCAT Damn Agendas! They're seemingly everywhere. But hmmm how do I know you aren't hiding an Agenda? Hmmm. Can't trust anyone.
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Post by Keybridge - Cult Member 003 on Nov 22, 2014 21:40:45 GMT
Paul Coffey is a professor at University College London - sure is.
I like the smell of desperation in the morning.
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Post by HeyNow on Nov 22, 2014 21:42:05 GMT
Youve recently said MA09 can not be commercialized and also explicitely said they were not cGMP compliant (which thankfully youve walked back from after learning you were wrong). Such definitive statements without any convincing evidence is a little irresponsible. I could have worded it better to avoid confusion, but I don't view the claim as irresponsible at all. I think you are being a bit fanatical about this. My point was MA09 apparently was not derived under full cGMP conditions, because the IVF clinic was not a cGMP IVF laboratory during the PGD screening (single-blastomere method). And the experts seem to agree ... << Examples were provided of hESC-derived cell therapies that had apparently not met the full donor eligibility requirements but had, to date, been able to enter early phase clinical trials in the U.S. It is unclear whether these cell lines will be suitable for licensure. >> << Whiting and Carpenter also raised the issue of the timing for using good manufacturing practices throughout a product’s life cycle. Some early cell lines now in the development pipeline were not derived under cGMP conditions but were banked under cGMP conditions. >> You have no way of knowing if those quotes even refer to MA09, nor if they have any merit based on the info you can independantly find and post, 50 pages a clip. Fanatical... good one. Be glad im here to actually hold you to account, otherwise it would probably become message board dogma that MA09 is not commercializable or worse (according to your original assertion) the unbelievable claim that they are not cGMP compliant. Thankfully we are past that claim, i hope.
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Post by tradeup on Nov 22, 2014 21:42:42 GMT
"West is considered to be a pioneer in the field of human embryonic stem cell. He founded Menlo Park-based Geron and also worked with Alameda-based Advanced Cell Technology. "Mike is a great visionary in this field who has always been way ahead of the curve in his thinking," said Chris Mason, a professor at University College London in England, who collaborated with West on the project. "And of all that he's done, this might be one of the most important." Just a wild guess, but Mason has a close relationship with West, and may be just showing support to West. Not sure I would read anything into Mason's retweet, other than a pat on the back. Just to be clear, Chris Mason "favorited" the post, which suggests that he strongly agrees with it. It was a retweet by Alexey Bersenev, who is considered an expert and global educator about clinical applications of stem cells. Even so, this is little more than anecdotal support for what I am suggesting are issues for MA09 licensure. Everyone should do their own due diligence on this topic. I look forward to investing in OCAT again when it is further diluted, oversold and there is money to be made.
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agendaman
New Member
Wherever Agenda Lurks, AgendaMan will Uncover it!
Posts: 10
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Post by agendaman on Nov 22, 2014 21:43:07 GMT
Paul Coffey is a professor at University College London - sure is. I like the smell of desperation in the morning. My brother ShortsAreDesperateMan would be interested in taking this assignment. I'll drop him a note.
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Post by tradeup on Nov 22, 2014 21:46:11 GMT
Management has tuned over since Rabin made those remarks. Wotton and his team have commented that the MA09 line is sufficient to commercialize. Wotton's comments prime those of Rabin, if for no other reason that Wotton's statements are current based on the company's discussions with the FDA. Do you have evidence of that comment? I read the transcript and I think you are misinterpreting a vague response to a specific question.
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Post by HeyNow on Nov 22, 2014 21:47:26 GMT
Paul Coffey is a professor at University College London - sure is. I like the smell of desperation in the morning. My brother ShortsAreDesperateMan would be interested in taking this assignment. I'll drop him a note. Eig?
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Post by Keybridge - Cult Member 003 on Nov 22, 2014 21:51:43 GMT
Management has tuned over since Rabin made those remarks. Wotton and his team have commented that the MA09 line is sufficient to commercialize. Wotton's comments prime those of Rabin, if for no other reason that Wotton's statements are current based on the company's discussions with the FDA. Do you have evidence of that comment? I read the transcript and I think you are misinterpreting a vague response to a specific question. I was sitting 10 feet from Wotton - not only were his comments indicative that there is no concern over commercializing the MA09 line, but his demeanor and body language were entirely consistent with his lack of concern. Take that to the bank.
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Post by HeyNow on Nov 22, 2014 21:58:25 GMT
Do you have evidence of that comment? I read the transcript and I think you are misinterpreting a vague response to a specific question. I was sitting 10 feet from Wotton - not only were his comments indicative that there is no concern over commercializing the MA09, but his demeanor and body language were entirely consistent with his lack of concern. Take that to the bank. Michael West told bullard who told tradeup that "some" cell lines might be problematic - then he winked. With evidence like that to the contrary, Im hard pressed to believe you Key.
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Post by Keybridge - Cult Member 003 on Nov 22, 2014 22:03:58 GMT
I was sitting 10 feet from Wotton - not only were his comments indicative that there is no concern over commercializing the MA09, but his demeanor and body language were entirely consistent with his lack of concern. Take that to the bank. Michael West told bullard who told tradeup that "some" cell lines might be problematic - then he winked. With evidence like that to the contrary, Im hard pressed to believe you Key. I hear you - I sometimes can't even look myself in the mirror.
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Post by actcrazy on Nov 22, 2014 22:09:10 GMT
Pfizer, Coffey, Dunhill, Mason, West and last, Bullard. Now I know some more possible wrench throwers for naught. Go Ocat
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Post by tradeup on Nov 22, 2014 22:17:00 GMT
Do you have evidence of that comment? I read the transcript and I think you are misinterpreting a vague response to a specific question. I was sitting 10 feet from Wotton - not only were his comments indicative that there is no concern over commercializing the MA09 line, but his demeanor and body language were entirely consistent with his lack of concern.
Take that to the bank. Rabin didn't seem too concerned either ... about anything. I don't suggest anyone factor in CEO body language into their financial decisions. The only thing I'm taking to the bank are my sizable profits this year.
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Post by i(n) sight on Nov 22, 2014 22:47:54 GMT
Paul Coffey is a professor at University College London - sure is. I like the smell of desperation in the morning. My brother ShortsAreDesperateMan would be interested in taking this assignment. I'll drop him a note. Or maybe their brothers, Let’sPaintOcatAPotemkinVillage and FabianMovementCuzWeCan
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Post by Keybridge - Cult Member 003 on Nov 22, 2014 23:53:21 GMT
Management has tuned over since Rabin made those remarks. Wotton and his team have commented that the MA09 line is sufficient to commercialize. Wotton's comments prime those of Rabin, if for no other reason that Wotton's statements are current based on the company's discussions with the FDA. Do you have evidence of that comment? I read the transcript and I think you are misinterpreting a vague response to a specific question.Expl Explain to me how it's misinterpreted? Your argument is very patchwork to say the least…if you can't make the argument in two paragraphs or less, then you're probably trying too hard to make a point that doesn't exist.
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Post by tradeup on Nov 23, 2014 0:52:44 GMT
Do you have evidence of that comment? I read the transcript and I think you are misinterpreting a vague response to a specific question. Explain to me how it's misinterpreted? Your argument is very patchwork to say the least…if you can't make the argument in two paragraphs or less, then you're probably trying too hard to make a point that doesn't exist. (ASM 2014) Q: NED lines, will there be a bridge of cell lines? Wotton: We have a lot of alternative cell lines at the company. Without giving a specific answer to the question because of the nature of confidentiality here, I would say the manufacturing team is completely on top of this, as is the development team in terms of working with the agency and both here FDA and the other control agencies are extremely supportive here, very helpful.
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Post by tradeup on Nov 23, 2014 1:11:37 GMT
University College London , isn't that where Prof. P. Coffey is working out of? hmm? Now, this well connected in the Reg. Med. field Chris Mason who is also a senior partner at Proteus Venture, might have an agenda? Disclosure; I'm not a fan of Dr. West. All fishy smelly..imo. Go OCAT You might as well include Stephen Minger (Global Head of Research and Development for the Cell Technologies at GE) into your "agenda" theory. Chris Mason and GE's Stephen Minger co-founded the London Regenerative Medicine Network (LRMN) and were co-winners of the Outstanding Contribution to London Biotechnology Award. So I guess this means no platelets JV with GE? Hmmm.
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Post by Keybridge - Cult Member 003 on Nov 23, 2014 1:19:02 GMT
Q: MAO9 lines not xeno free. Does that matter with agencies, can commercialize?
A: (Paul) 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
There is no ambiguity in the above quote that the MA09 may be commercialized - that this is not a regulatory matter. Wotton also followed up with another statement right after that one, essentially repeating that the FDA just cares about result - almost in a manner as if to say "in the real world that's what the FDA is concerned with."
Trade, you're unfortunately misunderstanding the point of Wotton's comments. He's indicating that they may bridge to alternative lines, but that's because it makes business sense to have a diversity of lines that the company has in its banks and are available to commercialize - but taken together with the other quote, this is not a regulatory necessity, but rather a possible business decision that they may be reviewing (perhaps with potential partners) that they just can't discuss.
I believe they will eventually create another line - but that's not a risk, that's a plus.
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Post by jeff on Nov 23, 2014 1:25:26 GMT
Rabin didn't seem too concerned either ... about anything.
I don't suggest anyone factor in CEO body language into their financial decisions. The only thing I'm taking to the bank are my sizable profits this year. [/quote]
Rabin mah not have been overly concerned about complying with SEC reporting requirements, or maybe not so concerned with ensuring the folks dealing with his trades were followe SEC rules (benevolent neglect?) but he was clearly concerned with SOME things of consequence to ACT investors--like bailing is out of a pretty gnarly set of financing relationships.
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Post by tradeup on Nov 23, 2014 1:38:44 GMT
Q: MAO9 lines not xeno free. Does that matter with agencies, can commercialize? A: (Paul) 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 confidenceThere is no ambiguity in the above quote that the MA09 may be commercialized - that this is not a regulatory matter. Wotton also followed up with another statement right after that one, essentially repeating that the FDA just cares about result - almost in a manner as if to say "in the real world that's what the FDA is concerned with." Trade, you're unfortunately misunderstanding the point of Wotton's comments. He's indicating that they may bridge to alternative lines, but that's because it makes business sense to have a diversity of lines that the company has in its banks and are available to commercialize - but taken together with the other quote, this is not a regulatory necessity, but rather a possible business decision that they may be reviewing (perhaps with potential partners) that they just can't discuss. I believe they will eventually create another line - but that's not a risk, that's a plus. Sounds to me like Wotton is referring to clinical trial progress, not licensure. Maybe investors should reach out to the company and get assurance on this topic. I would like to see their response.
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