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Post by Keybridge - Cult Member 003 on Dec 8, 2014 18:37:25 GMT
Dr. Wotton also said the following during the roadshow comments: "We estimate from the market research that we just conducted, it's probably up to about 165,000 cases of advanced dry AMD diagnosed every year where central geographic atrophy is present. And this is the target we're going after in the clinical trial program." My impression is that this is low hanging fruit in the AMD market. And my recollection is that Wotton believes there are certain sub-categories that might be carved out for Orphan treatment by the FDA. |
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Post by bballerfanatic on Dec 8, 2014 18:38:57 GMT
Again I'll try to explain this. Vitrectomy surgery can sometimes cause a cataract. This has been know for many years. It can happen when a vitrectomy is performed for any medical reason. Some of the most common reasons are: Diabetic vitreous hemorrhage Retinal detachment Epiretinal membrane Macular hole Proliferative vitreoretinopathy Endophthalmitis Intraocular foreign body removal Retrieval of lens nucleus following complicated cataract surgery Since Ocata's therapy requires a vitrectomy they knew that some patients would inevitably develop a cataract. This is not a surprise. Some patients in the Lancet recorded VA gains despite this newly forming cataract. So once again what's your point? You are failing to understand a simple concept: the limited data on 2a patients is likely not going to be "stellar" (as you say) when surgical complications occurred (cataracts) with multiple patients which obfuscates the results. Tradeup, I guess we are going to have to disagree on this one. I just cannot accept that a known possible result of an existing surgery would obfuscate the results. |
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Post by HeyNow on Dec 8, 2014 18:40:34 GMT
Surgical complications occurred in the regular cohort patients too. 5/18 of the patients reported in the Lancet publication developed cataracts yet the curated data was still informative, or "meaningful" (as you say). At the time of data submission for that paper though, there were probably only a couple of 2a patients with sufficient follow up (1 year) making those data too small of a sample size to evaluate. Once the trial is complete though they will have n=8 so they should be able to glean something more definitive from those data, even if 2-3 developed cataracts I guess in that case I should not anticipate the cohort 2a data to be revealed immediately after uplist. 2a data in its entirety - I would tend to agree. Importantly, all of the data is constantly changing and growing so new/updated data releases of some kind can happen any time, most likely during quarterly calls and 10-Qs. For example, the Lancet article included 18 patients but the company could release TLD from 30+ patients any time I suppose, and that would include the higher dose cohorts. Given the trends I saw in the lancet paper and the company's indication they will use higher doses (as opposed to 50 or 100k cells), I think the next data release, whether that comes as TLD at trial completion or some other time, has a chance to be even stronger then what was revealed in the Lancet article, since it will include newer data from all of the highest dosed patients |
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Post by actcfan on Dec 8, 2014 18:59:15 GMT
Dr. Wotton also said the following during the roadshow comments: "We estimate from the market research that we just conducted, it's probably up to about 165,000 cases of advanced dry AMD diagnosed every year where central geographic atrophy is present. And this is the target we're going after in the clinical trial program." My impression is that this is low hanging fruit in the AMD market. And my my recollection is that Wotton believes there are certain sub-categories that might be carved out for Orphan treatment by the FDA. I think Wooton and management are taking their ques from Lanza's team and the clinicians (SAB/KOL's of the trials). Rosenfeld pretty much laid out targeting this portion of the population where GA is present 2.5 years ago, knowing that they would need a population and approach to be able to show improvement to the FDA. JMHO www.youtube.com/watch?v=qKbwe6uqNPk |
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Post by Keybridge - Cult Member 003 on Dec 8, 2014 19:13:47 GMT
My impression is that this is low hanging fruit in the AMD market. And my my recollection is that Wotton believes there are certain sub-categories that might be carved out for Orphan treatment by the FDA. I think Wooton and management are taking their ques from Lanza's team and the clinicians (SAB/KOL's of the trials). Rosenfeld pretty much laid out targeting this portion of the population where GA is present 2.5 years ago, knowing that they would need a population and approach to be able to show improvement to the FDA. JMHO www.youtube.com/watch?v=qKbwe6uqNPk Thanks Fan. The general question I have is does the company have a realistic path to target a sub-group of AMD that would be considered an Orphan indication by the FDA? If yes, that might create a range of new possibilities. |
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Post by selluwud on Dec 8, 2014 19:16:21 GMT
Can doctors know or predict what percentage of the photoreceptors in the affected area are dormant but not dead? Using this knowledge would seemingly predicate a successful restoration of visual acuity and strongly influence the outcome of the trials in a positive way. There may be some fine details we are not aware of that will be used in the inclusion criteria.
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horus
Junior Member
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Post by horus on Dec 8, 2014 19:38:48 GMT
You are failing to understand a simple concept: the limited data on 2a patients is likely not going to be "stellar" (as you say) when surgical complications occurred (cataracts) with multiple patients which obfuscates the results. Tradeup, I guess we are going to have to disagree on this one. I just cannot accept that a known possible result of an existing surgery would obfuscate the results. What's really exciting to me is that despite 4 patients developing cataracts during the trials half of them were able to overcome the cataract's "obfuscation" of their vision. In other words, the treatment was so effective at rescuing their vision that even a newly progressing cataract could not stop their gains in visual acuity. Directly from the Lancet: Two of the four patients who developed cataracts
(one with age-related macular degeneration and one with
Stargardt’s macular dystrophy) had a decrease in visual
acuity (three to 12 letters) during cataract progression, but
visual acuity returned to baseline after cataract surgery,
whereas the other two patients (both with Stargardt’s
macular dystrophy) had increases in visual acuity
(six to seven letters) during cataract progression, which
increased further after cataract surgery (nine to 15 letters).
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Post by CM kipper007 on Dec 8, 2014 19:44:18 GMT
Flirting with 7 today...
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Post by rickrick on Dec 8, 2014 19:52:12 GMT
One reason this thread has started over a few times is that it gets used as an overall ocata dialog thread instead of a 'daily pps movement' thread.
I know we are a relatively small posting group and it's easy to keep talking to each other in whatever thread is being posted in but I feel we should stay on topic as close as possible.
Since this is a new start of this thread let's keep the topic in it to it's title 'pps movement' so that it won't get carried away with so many pages.
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Post by selluwud on Dec 8, 2014 20:03:21 GMT
One reason this thread has started over a few times is that it gets used as an overall ocata dialog thread instead of a 'daily pps movement' thread. I know we are a relatively small posting group and it's easy to keep talking to each other in whatever thread is being posted in but I feel we should stay on topic as close as possible. Since this is a new start of this thread let's keep the topic in it to it's title 'pps movement' so that it won't get carried away with so many pages. Ok, the pps is moving up and down. There you go. |
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Post by Keybridge - Cult Member 003 on Dec 8, 2014 20:38:28 GMT
One reason this thread has started over a few times is that it gets used as an overall ocata dialog thread instead of a 'daily pps movement' thread. I know we are a relatively small posting group and it's easy to keep talking to each other in whatever thread is being posted in but I feel we should stay on topic as close as possible. Since this is a new start of this thread let's keep the topic in it to it's title 'pps movement' so that it won't get carried away with so many pages. Ok, the pps is moving up and down. There you go. Yep, stocks go up, stocks go down. Consistently up over three days on better than average volume - good sign. Wonder if our friends at Lincoln are still holding shares and causing some headwinds at $7? |
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Post by CM kipper007 on Dec 8, 2014 20:39:29 GMT
One reason this thread has started over a few times is that it gets used as an overall ocata dialog thread instead of a 'daily pps movement' thread. I know we are a relatively small posting group and it's easy to keep talking to each other in whatever thread is being posted in but I feel we should stay on topic as close as possible. Since this is a new start of this thread let's keep the topic in it to it's title 'pps movement' so that it won't get carried away with so many pages. Only being able to talk about the share price is going to make this thread quite restrictive, and I am not sure that is what Jham had in mind. The discussion lead from speculation that info from the company will have a positive/negative effect on the price. If that information was to come out as thought was being debated. I had no problems with the thread content so far as it was polite and informative. |
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Post by rickrick on Dec 8, 2014 20:56:56 GMT
One reason this thread has started over a few times is that it gets used as an overall ocata dialog thread instead of a 'daily pps movement' thread. I know we are a relatively small posting group and it's easy to keep talking to each other in whatever thread is being posted in but I feel we should stay on topic as close as possible. Since this is a new start of this thread let's keep the topic in it to it's title 'pps movement' so that it won't get carried away with so many pages. Only being able to talk about the share price is going to make this thread quite restrictive, and I am not sure that is what Jham had in mind. The discussion lead from speculation that info from the company will have a positive/negative effect on the price. If that information was to come out as thought was being debated. I had no problems with the thread content so far as it was polite and informative. I totally understand the thread was going fine. My thoughts are that this isn't the only thread on the forum, it's a a thread on a specific subject 'daily pps movement' and so I agree this thread could be very short and not a lot of activity at times (which is perfectly fine, it doesn't have to expand on a daily basis), but due to that it will keep it from getting 30 or more pages long due to conversation that is specific to the company but not necessarily to daily pps movement. Every post about ocata is one that can possibly affect pps, but that doesn't mean it is specific to daily movement. I agree every thread can be polite and informative but that doesn't particularly mean it is on topic. |
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Post by i(n) sight on Dec 8, 2014 21:56:19 GMT
Only being able to talk about the share price is going to make this thread quite restrictive, and I am not sure that is what Jham had in mind. The discussion lead from speculation that info from the company will have a positive/negative effect on the price. If that information was to come out as thought was being debated. I had no problems with the thread content so far as it was polite and informative. I totally understand the thread was going fine. My thoughts are that this isn't the only thread on the forum, it's a a thread on a specific subject 'daily pps movement' and so I agree this thread could be very short and not a lot of activity at times (which is perfectly fine, it doesn't have to expand on a daily basis), but due to that it will keep it from getting 30 or more pages long due to conversation that is specific to the company but not necessarily to daily pps movement. Every post about ocata is one that can possibly affect pps, but that doesn't mean it is specific to daily movement. I agree every thread can be polite and informative but that doesn't particularly mean it is on topic. It’s a bit confusing as there is no specificity as to where the topic went off of PPS discussion if at all. tradeup put forth his view of market cap with his mathematical points as justification relative to the timing of “meaningful data"; horus disagreed with this. Both views impact potential market cap/pps, and specifically the daily PPS thoughts of equity participants buying today and what that number "should" be today (and all this week). So, where did it go off topic in the thread? I don’t see how we can have a discussion of PPS in a vacuum. I do agree that some threads have gone tangential and we’re trying something different and appreciate your effort. |
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Post by JHam on Dec 8, 2014 21:58:14 GMT
We could also change the thread title to read "Daily Discussion" if you want.
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Post by mmeyrow on Dec 8, 2014 22:02:19 GMT
It will be interesting to see If we break through 7 tomorrow morning
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Post by tradeup on Dec 8, 2014 22:48:03 GMT
tradeup put forth his view of market cap with his mathematical points as justification relative to the timing of “meaningful data"; horus disagreed with this. Both views impact potential market cap/pps, and specifically the daily PPS thoughts of equity participants buying today and what that number "should" be today (and all this week). Clarification: "Meaningful" as in having a major impact on share price (in context of thread subject). I expect the next major data catalyst in the eye trials will be Phase 2 data and it's going to be a long wait. Top-line Phase 1 data may prove to be a catalyst in 2015, but do people really expect it to exceed or differ much from market expectations following the Lancet results? |
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Post by tmfbmf on Dec 8, 2014 23:02:13 GMT
tradeup put forth his view of market cap with his mathematical points as justification relative to the timing of “meaningful data"; horus disagreed with this. Both views impact potential market cap/pps, and specifically the daily PPS thoughts of equity participants buying today and what that number "should" be today (and all this week). Clarification: "Meaningful" as in having a major impact on share price (in context of thread subject). I expect the next major data catalyst in the eye trials will be Phase 2 data and it's going to be a long wait. Top-line Phase 1 data may prove to be a catalyst in 2015, but do people really expect it to exceed or differ much from market expectations following the Lancet results? Then why are you trying to buy now? Why not wait until 2016? |
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Post by CM kipper007 on Dec 8, 2014 23:04:42 GMT
tradeup put forth his view of market cap with his mathematical points as justification relative to the timing of “meaningful data"; horus disagreed with this. Both views impact potential market cap/pps, and specifically the daily PPS thoughts of equity participants buying today and what that number "should" be today (and all this week). Clarification: "Meaningful" as in having a major impact on share price (in context of thread subject). I expect the next major data catalyst in the eye trials will be Phase 2 data and it's going to be a long wait. Top-line Phase 1 data may prove to be a catalyst in 2015, but do people really expect it to exceed or differ much from market expectations following the Lancet results? Phase 2 data may be a long-ish wait. But there's more going on than just the eye p2 trials. I still think that we will see some news accompany the uplist to give the new share holders some reassurance of their purchase. "Expectations following Lancet results"? Not really sure I understand where you are coming from. Market expectations prior to the results saw $12. Then, in-conjunction of results, the company released news of the shelf, we rallied to $9, then fell. Post Lancet has had a dark cloud over the company for some regarding the cash situation. If the company released great news with not other bad news to follow I expect to see a rapid increase in PPS. Of course there will be some erosion, but with no bad news, the general trend will be north. What are you expecting to happen from now, we just float in the $6-$7 range until commercialization? |
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Post by tradeup on Dec 8, 2014 23:08:52 GMT
Clarification: "Meaningful" as in having a major impact on share price (in context of thread subject). I expect the next major data catalyst in the eye trials will be Phase 2 data and it's going to be a long wait. Top-line Phase 1 data may prove to be a catalyst in 2015, but do people really expect it to exceed or differ much from market expectations following the Lancet results? Then why are you trying to buy now? Why not wait until 2016? Peaks and valleys, tmfbmf ... as far as the eye can see  |
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