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Post by bballerfanatic on Dec 8, 2014 17:12:03 GMT
So the remaining data from the Phase 1 better vision cohorts won't me meaningful? I tend to think it will be stellar.
Can you phase that a different way? I am not sure I understand the point you are trying to make. |
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horus
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Post by horus on Dec 8, 2014 17:19:40 GMT
True, any Vitrectomy for any medical reason has the chance to cause a cataract in the patient. That's been know for a long time. So what's your point?
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Post by HeyNow on Dec 8, 2014 17:28:29 GMT
So the remaining data from the Phase 1 better vision cohorts won't me meaningful? I tend to think it will be stellar. Could be. But it is interesting that OCAT is going after later stage patients with GA as their primary target market, not earlier stage patients as many here (including me) originally thought based on prior company statements. Not sure why that change in direction, as all commentary prior to the release of the Phase 2 endpoints was that earlier stage patients was the target. "But it is interesting that OCAT is going after later stage patients with GA as their primary target market" Jck - What are the inclusion/exclusion criteria for Phase 2 that makes you believe this? Were they mentioned in the roadshow or somewhere else recently? |
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Post by tradeup on Dec 8, 2014 17:29:05 GMT
I don't expect hearing about how 2a patients developed cataracts as a result of the procedure to be meaningful.
Can you phase that a different way? I am not sure I understand the point you are trying to make. Horus is expecting results from 2a to be "stellar." From the SHM we know there were surgical complications (i.e., cataracts) with multiple patients. Stellar? |
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Post by chuck on Dec 8, 2014 17:31:16 GMT
So the remaining data from the Phase 1 better vision cohorts won't me meaningful? I tend to think it will be stellar. Could be. But it is interesting that OCAT is going after later stage patients with GA as their primary target market, not earlier stage patients as many here (including me) originally thought based on prior company statements. Not sure why that change in direction, as all commentary prior to the release of the Phase 2 endpoints was that earlier stage patients was the target. I have been thinking about this too, Jckrdu. My guess is that they're accepting the fact that better vision patients have been tough to come by for this trial (see massive delays in P1) and early stage patients just dont want to take on the risk and the company doesn't want Phase 2 to take forever. They have decided to target the later stage patients for now, proving therapeutic effectiveness along the way, and will seek to target earlier stage patients down the road, IMO. Should help move this leg of the trial along in terms of patient enrollment and further establishing the therapy, which hopefully makes it easier to enroll earlier stage patients at some point. |
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PAL
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Post by PAL on Dec 8, 2014 17:34:29 GMT
So the remaining data from the Phase 1 better vision cohorts won't me meaningful? I tend to think it will be stellar. Could be. But it is interesting that OCAT is going after later stage patients with GA as their primary target market, not earlier stage patients as many here (including me) originally thought based on prior company statements. Not sure why that change in direction, as all commentary prior to the release of the Phase 2 endpoints was that earlier stage patients was the target. I didn't realize until our UB40 patient blog how disruptive this procedure really is. Not sure if his experience was unique given that he is a trial participant, but it makes me wonder if there's some question as to what stage potential patients will need to be in to legitimately consider having it done. Just thinking out loud about who will decide to have treatment and why and if the company wants to cater to those most likely to opt for it... |
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Post by actcfan on Dec 8, 2014 17:35:12 GMT
We shouldn't confuse this with an IPO, it's a secondary offering + uplist ("re-IPO") with 10-11.5M shares being added to the outstanding -- likely 11.5M. The price of $7 x 45.9M shares (34.4 + 11.5M) equals a Market Cap of approx $317M. We are many months away from P2 AMD initiation and 1.5-2.5 years away from meaningful data. I don't expect equity participants (myself included) to be buying at such a premium. So the remaining data from the Phase 1 better vision cohorts won't me meaningful? I tend to think it will be stellar. Horus, I am going by what the company is guiding, and I don't see anything about the better vision cohorts. It doesn't mean that data isn't good, but why are they not discussing publishing it? Maybe they accomplished what they wanted with the Lancet and prefer to look ahead to Phase 2 designed based on what they saw across all of phase 1?  |
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Post by jckrdu on Dec 8, 2014 17:36:10 GMT
Could be. But it is interesting that OCAT is going after later stage patients with GA as their primary target market, not earlier stage patients as many here (including me) originally thought based on prior company statements. Not sure why that change in direction, as all commentary prior to the release of the Phase 2 endpoints was that earlier stage patients was the target. I have been thinking about this too, Jckrdu. My guess is that they're accepting the fact that better vision patients have been tough to come by for this trial (see massive delays in P1) and early stage patients just dont want to take on the risk and the company doesn't want Phase 2 to take forever. They have decided to target the later stage patients for now, proving therapeutic effectiveness along the way, and will seek to target earlier stage patients down the road, IMO. Should help move this leg of the trial along in terms of patient enrollment and further establishing the therapy, which hopefully makes it easier to enroll earlier stage patients at some point. Chuck - That's my thinking as well. HeyNow - I'm going by a slidedeck in their latest presentation. Maybe there will be more detailed information on clinicaltrials.gov eventually, but latest slidedeck implies target is later stage patients that already have some GA. PW went on to talk about the size of that target market with some pretty specific numbers... something like 110k to 165k new patients per year being identified with that condition. |
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Post by actcfan on Dec 8, 2014 17:40:50 GMT
Could be. But it is interesting that OCAT is going after later stage patients with GA as their primary target market, not earlier stage patients as many here (including me) originally thought based on prior company statements. Not sure why that change in direction, as all commentary prior to the release of the Phase 2 endpoints was that earlier stage patients was the target. "But it is interesting that OCAT is going after later stage patients with GA as their primary target market" Jck - What are the inclusion/exclusion criteria for Phase 2 that makes you believe this? Were they mentioned in the roadshow or somewhere else recently? Tradeup, I think jck is referring to the below slide and the below comment from PW (and pm's transcript) from the roadshow: In the late form of dry AMD, you get geographic atrophy which leads to your vision loss in the center. 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. Severe dry AMD is important and it's easy for people to understand in terms of the value of this market, because it's the precursor to wet AMD, which is what both Lucentis and Eyelea are used to treat.
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horus
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Post by horus on Dec 8, 2014 17:41:32 GMT
Horus is expecting results from 2a to be "stellar." From the SHM we know there were surgical complications (i.e., cataracts) with multiple patients. Stellar? 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? |
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Post by chuck on Dec 8, 2014 17:42:02 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."
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Post by CM kipper007 on Dec 8, 2014 17:45:20 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." Does vision loss occur when GA starts? |
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Post by HeyNow on Dec 8, 2014 17:50:26 GMT
"But it is interesting that OCAT is going after later stage patients with GA as their primary target market" Jck - What are the inclusion/exclusion criteria for Phase 2 that makes you believe this? Were they mentioned in the roadshow or somewhere else recently? Tradeup, I think jck is referring to the below slide and the below comment from PW (and pm's transcript) from the roadshow: In the late form of dry AMD, you get geographic atrophy which leads to your vision loss in the center. 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. Severe dry AMD is important and it's easy for people to understand in terms of the value of this market, because it's the precursor to wet AMD, which is what both Lucentis and Eyelea are used to treat.
Thanks that's what I was looking for |
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Post by sidewinder on Dec 8, 2014 17:54:51 GMT
Can you phase that a different way? I am not sure I understand the point you are trying to make. Horus is expecting results from 2a to be "stellar." From the SHM we know there were surgical complications (i.e., cataracts) with multiple patients. Stellar? After all the stink regarding cataracts I find it most interesting that it’s made its way back into the conversation…. So, basically your saying that a KNOWN side effect to the delivery method used to dose these patients somehow detracts from the overall outcome? I’m cornfused…but then again corn’ll do that…especially if its fermented!!! |
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Post by tradeup on Dec 8, 2014 17:57:26 GMT
Horus is expecting results from 2a to be "stellar." From the SHM we know there were surgical complications (i.e., cataracts) with multiple patients. Stellar? 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. |
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Post by CM kipper007 on Dec 8, 2014 17:58:29 GMT
Tradeup, I think jck is referring to the below slide and the below comment from PW (and pm's transcript) from the roadshow: In the late form of dry AMD, you get geographic atrophy which leads to your vision loss in the center. 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. Severe dry AMD is important and it's easy for people to understand in terms of the value of this market, because it's the precursor to wet AMD, which is what both Lucentis and Eyelea are used to treat.
Thanks that's what I was looking for I might need someone to correct my understanding, but the GA is the loss of the RPE cells. Once they die off, then the rods and cones will follow. But GA could occur in different locations, albeit a small area. If they were to inject cells prior to GA, could they place them in a somewhat healthy area, and miss where GA is occurring? Woulds it be logical that they are looking for patients where the GA has recently occurred, hit them in that specific area to save the rods/cones? |
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Post by forthefuture on Dec 8, 2014 18:03:22 GMT
Thanks that's what I was looking for I might need someone to correct my understanding, but the GA is the loss of the RPE cells. Once they die off, then the rods and cones will follow. But GA could occur in different locations, albeit a small area. If they were to inject cells prior to GA, could they place them in a somewhat healthy area, and miss where GA is occurring? Woulds it be logical that they are looking for patients where the GA has recently occurred, hit them in that specific area to save the rods/cones? Kipper, my understanding is that GA is a result of the loss in photoreceptors. |
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Post by HeyNow on Dec 8, 2014 18:06:02 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. 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 |
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Post by dayanand33 on Dec 8, 2014 18:30:45 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. 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. |
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Post by dayanand33 on Dec 8, 2014 18:36:11 GMT
Could be. But it is interesting that OCAT is going after later stage patients with GA as their primary target market, not earlier stage patients as many here (including me) originally thought based on prior company statements. Not sure why that change in direction, as all commentary prior to the release of the Phase 2 endpoints was that earlier stage patients was the target. I have been thinking about this too, Jckrdu. My guess is that they're accepting the fact that better vision patients have been tough to come by for this trial (see massive delays in P1) and early stage patients just dont want to take on the risk and the company doesn't want Phase 2 to take forever. They have decided to target the later stage patients for now, proving therapeutic effectiveness along the way, and will seek to target earlier stage patients down the road, IMO. Should help move this leg of the trial along in terms of patient enrollment and further establishing the therapy, which hopefully makes it easier to enroll earlier stage patients at some point. The procedure is deemed to be safe, although painful. Anyone knowing he/she is about to turn blind (cohort 2a patients) will still want to be a part of the trial. I find it difficult to convince myself that lack of patients is causing the delay. |
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