|
|
Post by imz72 on Aug 6, 2021 10:14:49 GMT
Athersys Partner HEALIOS K.K. Announces Positive Topline Results of MultiStem for Acute Respiratory Distress Syndrome in the ONE-BRIDGE Study
August 06, 2021 Athersys to continue to provide close support to Healios to advance its ARDS program
CLEVELAND--(BUSINESS WIRE)-- Athersys, Inc. (NASDAQ: ATHX) announced today that its partner in Japan, HEALIOS K.K. (Healios), has released positive topline data from its ONE-BRIDGE clinical trial evaluating the safety and efficacy of MultiStem® cell therapy (invimestrocel) in patients with acute respiratory distress syndrome (ARDS). The details are provided in Healios’ press release: ssl4.eir-parts.net/doc/4593/tdnet/2010473/00.pdfThe ONE-BRIDGE study in Japan is an open-label trial with two patient cohorts – one, with 30 pneumonia-induced ARDS subjects including treatment and registry groups, and a second, with five COVID-induced ARDS subjects. Healios reported favorable topline results for both cohorts relative to the registry and expectations for these patients, including the primary endpoint of ventilator-free days (VFD) and the secondary endpoint of 90-day mortality. These data are in line with the results from Athersys’s placebo-controlled MUST-ARDS study, conducted with a similar patient population in the United States and the United Kingdom. MultiStem cell therapy (HLCM051) has been designated in Japan as an orphan regenerative medicine product for use in the treatment of ARDS. "We are excited by the results reported by our partner, Healios," commented Mr. William (B.J.) Lehmann, Jr., President, and Interim CEO of Athersys. "We continue to believe that MultiStem administration can have a meaningful therapeutic impact for ARDS patients. We look forward to continuing to support Healios as it moves the ARDS program forward in Japan and as we make progress elsewhere." Athersys is currently conducting its MACoVIA study, a double-blind, placebo-controlled study evaluating MultiStem administration in patients with ARDS resulting from COVID-19 and other pathogens. Athersys’s ARDS program has received Fast Track and Regenerative Medicine Advanced Therapy (RMAT) designations from the United States Food and Drug Administration. www.athersys.com/investors/press-releases/press-release-details/2021/Athersys-Partner-HEALIOS-K.K.-Announces-Positive-Topline-Results-of-MultiStem-for-Acute-Respiratory-Distress-Syndrome-in-the-ONE-BRIDGE-Study/default.aspx
|
|
|
|
Post by selluwud on Aug 6, 2021 11:24:47 GMT
It's about damn time. Nice pre-market action so far. I hope the runway is clear for launch...........do not want to hear any "but"s
|
|
|
|
Post by CM kipper007 on Aug 6, 2021 22:40:04 GMT
It's about damn time. Nice pre-market action so far. I hope the runway is clear for launch...........do not want to hear any "but"s It is great news, but it is just the first step. Would be great to get a paper written in a publication. They get better information on the application to get this approved. On a side note, I am getting very tired of the cry babies on the reddit board. Some of these people need to be spoon fed. I really don't get the hostility towards Hardy. He has literally dragged us over a finish line that we couldn't do ourselves. |
|
|
|
Post by tmfbmf on Aug 9, 2021 23:54:55 GMT
226,225,093 shares outstanding on 8/9, same as on 6/22. No sales to Aspire for a month and a half. Hopefully, it continues.
|
|
|
|
Post by imz72 on Aug 10, 2021 9:23:47 GMT
Healios announces completion of TREASURE enrollment:
ssl4.eir-parts.net/doc/4593/tdnet/2013098/00.pdf"The study was planned for 220 patients and Healios determined that enrolment was completed after a period of follow up to ensure any dropouts would not have an impact on data calculations" Healios Q2 2021 presentation:
ssl4.eir-parts.net/doc/4593/tdnet/2013100/00.pdfSlide 7: "Q4 2021 target for the announcement of top-line results" (of Treasure) Slide 4: Target for applying (for ARDS approval) - Q4 2021 / Q1 2022
|
|
|
|
Post by twenty2 on Aug 10, 2021 19:29:52 GMT
Athersys (ATHX) Q2 2021 Earnings Call TRANSCRIPT... ATHX earnings call for the period ending June 30, 2021 - linkand... 8/9/21 ATHX FORM 10-Q - link
(In part from page 21 of 10-Q) As previously disclosed, on February 16, 2021, we entered into a cooperation agreement, (the “Cooperation Agreement”) with Healios and Dr. Tadahisa Kagimoto pursuant to which Healios agreed to certain customary standstill provisions, effective as of the date of the Cooperation Agreement and continuing through the conclusion of our 2022 annual meeting of stockholders (the “Standstill Period”). These provisions prohibit Healios from, among other things, acquiring securities that would result in Healios beneficially owning more than 9.9% of our outstanding shares of common stock, inclusive of Healios’s current holdings (the “Ownership Limitation”) and engaging in certain other actions with respect to our stockholder meetings or securities. In addition, under the Cooperation Agreement, during the Standstill Period, we agree to provide notice to Healios of certain equity issuances and to allow Healios to participate in certain issuances to maintain its proportionate ownership of our common stock as of the time of such issuance, subject to a maximum participation of 19.9% of any such issuance, and subject to the Ownership Limitation. In connection with the execution of the Framework Agreement, we entered into an amendment to the Cooperation Agreement with Healios to extend the Standstill Period for the provisions described above until the conclusion of our 2023 annual meeting of stockholders. The amendment to the Cooperation Agreement also provides that the Warrant Shares will be excluded from the calculation of the Ownership Limitation. and... twenty2 |
|
|
|
Post by twenty2 on Aug 10, 2021 21:19:24 GMT
and... Hardy post at Linkedin - link
twenty2 |
|
|
|
Post by jamesjohnson12 on Aug 12, 2021 20:15:37 GMT
Hey guys, Just wanted to gauge what the other shareholders on here are thinking. I am pretty ecstatic with the past month: - Solid ARDS data as expected
- Timeline to submit for approval on ARDS data (4th Quarter/1st quarter 2022)
- Expanded business agreement between ATHX and Helios (Appear to have mended that relationship and incentivized Healios to shine, which they have)
- Manufacturing Tech Transfer to Healios (seems like a necessary prerequisite for forthcoming sales in Japan, which is very bullish)
- Treasure Enrollment Completion
It seems to me that we have some huge catalysts and binary events on the horizon (namely the filing for ARDS approval and Treasure Top line results) and they could be as little as 3 months away.
I am a little surprised at the lack of action on PPS...I suppose that Aspire has a large stockpile of shares that they may be selling into the increased buying, but from the Q2 financials, it looks like ATHX has stopped selling to Aspire. I find the fact that they are not selling to Aspire pretty bullish as it means that they are confident that they can sell at a higher price later (after some of the catalysts hit) or they think they may have partner in the mid term (maybe Q1/Q2 next year). I also get that this is ATHX and basically have learned to go into anything with lowered/no expectations haha.
I am already overweight (15% of portfolio), but am contemplating making another significant purchase since it would essentially be at my long term cost basis for the rest of my shares, which I find truly incredible. I believe that the risk profile is the lowest it has ever been for this stock and that great things are on the horizon for the next 6 months. I would love to get a huge run up and sell a bunch of covered calls...
Wanted to get others thoughts and comments on the recent happenings.
When do you all think we sign a partnership?
I am guessing Q2 after receiving a fast approval for ARDS (hopefully) and receiving brilliant Treasure results in November/December.
ATHX has been holding out for a partnership until after results. I wonder what their threshold is for what they're willing to accept. Do you think they are holding out for a 50-100mm share purchase at $5-$10/share or something even bigger? I know the company and plan makes all the difference, but clearly they are holding out for a better price as well.
When do you all think we sign a CEO? Before or after partnership?
When do you think we see first sales in Japan? Will we have sales in 2022?
Just wanted to provoke some discussion here and maybe amp up the enthusiasm haha!
|
|
|
|
Post by eitherhalf on Aug 12, 2021 22:02:49 GMT
Hell, I'm just excited to see who show's up on the thread cause it's mostly been crickets since I bought in. Happy to see people interested again and see who is holding, I was beginning to think I was crazy for buying......now I am pretty excited to find out who my fellow investors are!!
|
|
|
|
Post by twenty2 on Aug 13, 2021 9:26:12 GMT
and...Educational Thread at reddit...
Posted by u/Lovinglife62 (22 hours ago)
"Looking for opinions? (Discussion)
Based on what we know on post hoc data of Masters 1 and add in the 6 hour earlier treatment window of 18 hours instead of 24. What are reasonable odds that the Treasure trial shows statistically significant positive results?" - linktwenty2
|
|
|
|
Post by jckrdu on Aug 13, 2021 12:37:01 GMT
Hey guys, Just wanted to gauge what the other shareholders on here are thinking. I am pretty ecstatic with the past month: - Solid ARDS data as expected
- Timeline to submit for approval on ARDS data (4th Quarter/1st quarter 2022)
- Expanded business agreement between ATHX and Helios (Appear to have mended that relationship and incentivized Healios to shine, which they have)
- Manufacturing Tech Transfer to Healios (seems like a necessary prerequisite for forthcoming sales in Japan, which is very bullish)
- Treasure Enrollment Completion
It seems to me that we have some huge catalysts and binary events on the horizon (namely the filing for ARDS approval and Treasure Top line results) and they could be as little as 3 months away.
I am a little surprised at the lack of action on PPS...I suppose that Aspire has a large stockpile of shares that they may be selling into the increased buying, but from the Q2 financials, it looks like ATHX has stopped selling to Aspire. I find the fact that they are not selling to Aspire pretty bullish as it means that they are confident that they can sell at a higher price later (after some of the catalysts hit) or they think they may have partner in the mid term (maybe Q1/Q2 next year). I also get that this is ATHX and basically have learned to go into anything with lowered/no expectations haha.
I am already overweight (15% of portfolio), but am contemplating making another significant purchase since it would essentially be at my long term cost basis for the rest of my shares, which I find truly incredible. I believe that the risk profile is the lowest it has ever been for this stock and that great things are on the horizon for the next 6 months. I would love to get a huge run up and sell a bunch of covered calls...
Wanted to get others thoughts and comments on the recent happenings.
When do you all think we sign a partnership?
I am guessing Q2 after receiving a fast approval for ARDS (hopefully) and receiving brilliant Treasure results in November/December.
ATHX has been holding out for a partnership until after results. I wonder what their threshold is for what they're willing to accept. Do you think they are holding out for a 50-100mm share purchase at $5-$10/share or something even bigger? I know the company and plan makes all the difference, but clearly they are holding out for a better price as well.
When do you all think we sign a CEO? Before or after partnership?
When do you think we see first sales in Japan? Will we have sales in 2022?
Just wanted to provoke some discussion here and maybe amp up the enthusiasm haha!
Agree things are set-up well. On the pps action (or lack thereof), IMO the rather large 226M outstanding share count is a factor. IMO short-term traders that got in recently in the $1.50s and below are selling, but that supply is about to be exhausted. IMO, pps will continue to move up on expectations of all the catalysts coming. If you go back to page 1 of this 184 page thread, you'll see the posts when we were expecting Phase 2 stroke data in 2014. PPS ran from $1ish to over $3 that time pre-data, but that was with almost half the share count. I'm not expecting more than $3-$4 pre-stroke data ($700M - $900M market cap), just because ATHX revenues/profits are a little farther down the road based on where ATHX trials are at. I've been steadily accumulating and will continue to buy anywhere under $2. Highly likely ARDS gets approved in Japan, which IMO makes ATHX a $1B+ market cap company as a floor. Risk/reward has never been better in ATHX. If Japan stroke data meets 90 day end point, only question us stockholders will have is when to sell... $10, $20, $30, $40, $50..... $100? If stroke meets 90 day endpoints (and then another time at bat if needed for 365 day data mid-2022), that's the trajectory ATHX will be on.  |
|
|
|
Post by imz72 on Aug 13, 2021 13:59:12 GMT
Healios CFO Richard Kincaid, Q2 2021 results briefing (8.13.2021):
"We believe in these cells, we can see that they work."
|
|
|
|
Post by tmfbmf on Aug 13, 2021 14:14:24 GMT
I think the market is in no hurry to rush into Athersys. We probably won't get any news for a couple of months.
Stroke readout is Q4. I think this will be an historic event and get worldwide coverage, but the market probably doesn't care yet because they looked up the headlines of the PII US trial and assume this will be another failure. I think we'll easily hit the end points and get full approval and be able to use those results to bolster our US/Euro applications next year. Or next next year? But, the market doesn't care what I think. Let's see the data!
ARDS trial ends end of September. Hardy is a hype man. I'm not saying the hype is wrong, but I think a lot of potential investors don't fully trust him. The median VFD look great! But how much worse are the mean data? Why were 30% of the placebo pts not included in the mortality percentage? I, and I assume the market, still have lots of questions about the ARDS data. But, I also think median is a better indicator than the mean in small studies. I think the median VFD Hardy reported is good enough to get us conditional approval. As an ATHX investor, I don't care if Healios gets full or conditional approval. I guess I prefer conditional approval bc then they have to do a post market study and we get more clinical data eventually. Will Hardy get Athersys to foot some of the bill? He seems good at that. Anyway, not a big deal. I think the main reason Healios is on a run and Athersys is not is bc outside of Japan people still don't really understand how easy it is to get approved. We will get conditional approval in Japan for ARDS based on our 30 pt study and their 35 pt study. I'm sure of it, but the market will only believe this when they see it.
Anyway, all just my opinion, but we probably have another month to accumulate at this level. In Oct I predict a slow steady rise. I think ARDS data doesn't send us to the mOoN (but approval in Q1 or Q2 will). I can't even predict the pps after stroke data. I've been waiting for a long time! Finally we're close.
|
|
|
|
Post by jamesjohnson12 on Aug 13, 2021 14:36:04 GMT
Hey guys, Just wanted to gauge what the other shareholders on here are thinking. I am pretty ecstatic with the past month: - Solid ARDS data as expected
- Timeline to submit for approval on ARDS data (4th Quarter/1st quarter 2022)
- Expanded business agreement between ATHX and Helios (Appear to have mended that relationship and incentivized Healios to shine, which they have)
- Manufacturing Tech Transfer to Healios (seems like a necessary prerequisite for forthcoming sales in Japan, which is very bullish)
- Treasure Enrollment Completion
It seems to me that we have some huge catalysts and binary events on the horizon (namely the filing for ARDS approval and Treasure Top line results) and they could be as little as 3 months away.
I am a little surprised at the lack of action on PPS...I suppose that Aspire has a large stockpile of shares that they may be selling into the increased buying, but from the Q2 financials, it looks like ATHX has stopped selling to Aspire. I find the fact that they are not selling to Aspire pretty bullish as it means that they are confident that they can sell at a higher price later (after some of the catalysts hit) or they think they may have partner in the mid term (maybe Q1/Q2 next year). I also get that this is ATHX and basically have learned to go into anything with lowered/no expectations haha.
I am already overweight (15% of portfolio), but am contemplating making another significant purchase since it would essentially be at my long term cost basis for the rest of my shares, which I find truly incredible. I believe that the risk profile is the lowest it has ever been for this stock and that great things are on the horizon for the next 6 months. I would love to get a huge run up and sell a bunch of covered calls...
Wanted to get others thoughts and comments on the recent happenings.
When do you all think we sign a partnership?
I am guessing Q2 after receiving a fast approval for ARDS (hopefully) and receiving brilliant Treasure results in November/December.
ATHX has been holding out for a partnership until after results. I wonder what their threshold is for what they're willing to accept. Do you think they are holding out for a 50-100mm share purchase at $5-$10/share or something even bigger? I know the company and plan makes all the difference, but clearly they are holding out for a better price as well.
When do you all think we sign a CEO? Before or after partnership?
When do you think we see first sales in Japan? Will we have sales in 2022?
Just wanted to provoke some discussion here and maybe amp up the enthusiasm haha!
Agree things are set-up well. On the pps action (or lack thereof), IMO the rather large 226M outstanding share count is a factor. IMO short-term traders that got in recently in the $1.50s and below are selling, but that supply is about to be exhausted. IMO, pps will continue to move up on expectations of all the catalysts coming. If you go back to page 1 of this 184 page thread, you'll see the posts when we were expecting Phase 2 stroke data in 2014. PPS ran from $1ish to over $3 that time pre-data, but that was with almost half the share count. I'm not expecting more than $3-$4 pre-stroke data ($700M - $900M market cap), just because ATHX revenues/profits are a little farther down the road based on where ATHX trials are at. I've been steadily accumulating and will continue to buy anywhere under $2. Highly likely ARDS gets approved in Japan, which IMO makes ATHX a $1B+ market cap company as a floor. Risk/reward has never been better in ATHX. If Japan stroke data meets 90 day end point, only question us stockholders will have is when to sell... $10, $20, $30, $40, $50..... $100? If stroke meets 90 day endpoints (and then another time at bat if needed for 365 day data mid-2022), that's the trajectory ATHX will be on. Absolutely! That definitely makes sense to me...I would prefer a steady increase in buying pressure and definitely can see that a lot of these sellers right now are probably momentum/swing traders that got in over the last 18 months and just want to get out. That makes sense that that pool will probably be drying up and allow the price to rise hopefully over the next 30 days. I started accumulating in 2016, I believe which feels like a long time. But reading some of the initial DD discussions is wild! Crazy to see how far we've come...still have a little further. I hope to take a little risk off the table hopefully around $10, but want to keep most of my shares while writing some covered calls after some of the anticipated run ups. If the shares get called, so be it! But, I think ATHX will be pretty volatile on the way up and expect to be able to keep most of my shares while making some serious premiums from the covered calls. That is my hope at least haha. Thanks for the good discussion guys. |
|
pata
Junior Member
Posts: 52 
|
Post by pata on Aug 14, 2021 15:22:53 GMT
jckrdu: "... If Japan stroke data meets 90 day end point, only question us stockholders will have is when to sell... $10, $20, $30, $40, $50..... $100? If stroke meets 90 day endpoints (and then another time at bat if needed for 365 day data mid-2022), that's the trajectory ATHX will be on. ..."
tmfbmf: "... Stroke readout is Q4. I think this will be an historic event and get worldwide coverage, but the market probably doesn't care yet because they looked up the headlines of the PII US trial and assume this will be another failure. ..."
Is it likely that the market believes the U.S. FDA's scrutiny will be more stringent than that of Japanese regulators? If so, would it only price in revenue from Japanese sales until MASTERS-2 completes and gains approval? In that case, will double digit share prices still be years away?
tmfbmf: "... I think the main reason Healios is on a run and Athersys is not is bc outside of Japan people still don't really understand how easy it is to get approved. We will get conditional approval in Japan for ARDS based on our 30 pt study and their 35 pt study. I'm sure of it, but the market will only believe this when they see it. ..."
Perhaps the market believes in the high likelihood of Japanese ARDS approval but estimates the revenue for Athersys from that is limited to ~$25M/year (and that U.S. approval for ARDS is still an unknown)? (Assumption: 8K/year Japanese patients, $20K/MultiStem treatment reimbursement, 15% Athersys royalty.)
|
|
|
|
Post by tmfbmf on Aug 14, 2021 16:00:12 GMT
jckrdu: "... If Japan stroke data meets 90 day end point, only question us stockholders will have is when to sell... $10, $20, $30, $40, $50..... $100? If stroke meets 90 day endpoints (and then another time at bat if needed for 365 day data mid-2022), that's the trajectory ATHX will be on. ..." tmfbmf: "... Stroke readout is Q4. I think this will be an historic event and get worldwide coverage, but the market probably doesn't care yet because they looked up the headlines of the PII US trial and assume this will be another failure. ..." Is it likely that the market believes the U.S. FDA's scrutiny will be more stringent than that of Japanese regulators? If so, would it only price in revenue from Japanese sales until MASTERS-2 completes and gains approval? In that case, will double digit share prices still be years away? tmfbmf: "... I think the main reason Healios is on a run and Athersys is not is bc outside of Japan people still don't really understand how easy it is to get approved. We will get conditional approval in Japan for ARDS based on our 30 pt study and their 35 pt study. I'm sure of it, but the market will only believe this when they see it. ..." Perhaps the market believes in the high likelihood of Japanese ARDS approval but estimates the revenue for Athersys from that is limited to ~$25M/year (and that U.S. approval for ARDS is still an unknown)? (Assumption: 8K/year Japanese patients, $20K/MultiStem treatment reimbursement, 15% Athersys royalty.) I don't know about ARDS approval in the US, but the FDA made their intentions clear about stroke. They told Gil to change the primary end point to mRS. And they gave us SPA, so if we hit the primary end point it's almost a guarantee of approval. This is not the same mRS that was reported in PII. There is no arbitrary level that needs to be met before datum is counted as a success. The shift analysis is done over the entire spectrum. I was assured by our former CEO that, had this been the primary end point in PII, even with all the mistakes made with patient enrollment, we would've hit the end point. The FDA is practically begging to approve this. |
|
pata
Junior Member
Posts: 52
|
Post by pata on Aug 14, 2021 18:05:00 GMT
Thanks. These are excellent points. Assuming the market is willing to extrapolate by applying the MASTERS-2 success criteria to the TREASURE data, and that primary endpoints are met, this bodes well for significant increase in valuation by mid-2022 then?
|
|
|
|
Post by jckrdu on Aug 15, 2021 12:41:31 GMT
Thanks. These are excellent points. Assuming the market is willing to extrapolate by applying the MASTERS-2 success criteria to the TREASURE data, and that primary endpoints are met, this bodes well for significant increase in valuation by mid-2022 then? Imo, very hard to say exactly when the market will start to value ATHX significantly higher. Imo, statistically significant stroke results in Japan should (fairly quickly) value ATHX at a $10 pps minimum (roughly $2.3B market cap), given the implications to ATHX future revenue stream. - Does the market discount the news because ATHX trial completion ("hoping" for stroke completion in 2022 per BJ)... then 90 days for endpoints + application time + approval time) and significant revenue is still farther out (late 2023 at the very earliest which is 2 years from now) because of where their trials sit?
- Does the move significantly higher only start to happen only after they execute a partnership post Japan stroke data?
Some things are just impossible to know. IMO, if Japan stroke data is positive (even of they miss primary (low probability) but meet the secondary MRS shift endpoint... meaning likely conditional approval in Japan at a minimum and full approval in the US per TMF's post on likelihood of MRS shift being met in US), it may take awhile (maybe years) but if they're not bought out beforehand, there's no reason why they wouldn't become a $10B+ market cap company as a conservative floor (approximate $40 pps with 250M shares issued). A partner is likely to provide the bulk of the capital needed to build out their manufacturing capability. Coupled with some modest dilution, I'm not concerned about their cash position, post positive stroke data. ATHX will become a very sound long-term hold if we just get "signs of efficacy" from Japan (a near certainty imo), and evidence that MRS shift was met. |
|
|
|
Post by jckrdu on Aug 15, 2021 12:52:40 GMT
jckrdu: "... If Japan stroke data meets 90 day end point, only question us stockholders will have is when to sell... $10, $20, $30, $40, $50..... $100? If stroke meets 90 day endpoints (and then another time at bat if needed for 365 day data mid-2022), that's the trajectory ATHX will be on. ..." tmfbmf: "... Stroke readout is Q4. I think this will be an historic event and get worldwide coverage, but the market probably doesn't care yet because they looked up the headlines of the PII US trial and assume this will be another failure. ..." Is it likely that the market believes the U.S. FDA's scrutiny will be more stringent than that of Japanese regulators? If so, would it only price in revenue from Japanese sales until MASTERS-2 completes and gains approval? In that case, will double digit share prices still be years away? tmfbmf: "... I think the main reason Healios is on a run and Athersys is not is bc outside of Japan people still don't really understand how easy it is to get approved. We will get conditional approval in Japan for ARDS based on our 30 pt study and their 35 pt study. I'm sure of it, but the market will only believe this when they see it. ..." Perhaps the market believes in the high likelihood of Japanese ARDS approval but estimates the revenue for Athersys from that is limited to ~$25M/year (and that U.S. approval for ARDS is still an unknown)? (Assumption: 8K/year Japanese patients, $20K/MultiStem treatment reimbursement, 15% Athersys royalty.) I don't know about ARDS approval in the US, but the FDA made their intentions clear about stroke. They told Gil to change the primary end point to mRS. And they gave us SPA, so if we hit the primary end point it's almost a guarantee of approval. This is not the same mRS that was reported in PII. There is no arbitrary level that needs to be met before datum is counted as a success. The shift analysis is done over the entire spectrum. I was assured by our former CEO that, had this been the primary end point in PII, even with all the mistakes made with patient enrollment, we would've hit the end point. The FDA is practically begging to approve this. Thanks Tmf. I remember you making that point years ago. Looking good. |
|
|
|
Post by jckrdu on Aug 15, 2021 15:04:59 GMT
jckrdu: "... If Japan stroke data meets 90 day end point, only question us stockholders will have is when to sell... $10, $20, $30, $40, $50..... $100? If stroke meets 90 day endpoints (and then another time at bat if needed for 365 day data mid-2022), that's the trajectory ATHX will be on. ..." tmfbmf: "... Stroke readout is Q4. I think this will be an historic event and get worldwide coverage, but the market probably doesn't care yet because they looked up the headlines of the PII US trial and assume this will be another failure. ..." Is it likely that the market believes the U.S. FDA's scrutiny will be more stringent than that of Japanese regulators? If so, would it only price in revenue from Japanese sales until MASTERS-2 completes and gains approval? In that case, will double digit share prices still be years away? tmfbmf: "... I think the main reason Healios is on a run and Athersys is not is bc outside of Japan people still don't really understand how easy it is to get approved. We will get conditional approval in Japan for ARDS based on our 30 pt study and their 35 pt study. I'm sure of it, but the market will only believe this when they see it. ..." Perhaps the market believes in the high likelihood of Japanese ARDS approval but estimates the revenue for Athersys from that is limited to ~$25M/year (and that U.S. approval for ARDS is still an unknown)? (Assumption: 8K/year Japanese patients, $20K/MultiStem treatment reimbursement, 15% Athersys royalty.) I don't know about ARDS approval in the US, but the FDA made their intentions clear about stroke. They told Gil to change the primary end point to mRS. And they gave us SPA, so if we hit the primary end point it's almost a guarantee of approval. This is not the same mRS that was reported in PII. There is no arbitrary level that needs to be met before datum is counted as a success. The shift analysis is done over the entire spectrum. I was assured by our former CEO that, had this been the primary end point in PII, even with all the mistakes made with patient enrollment, we would've hit the end point. The FDA is practically begging to approve this. Hey Tmf - Can you elaborate on the bolded statement above? What is the difference between the "mRS" endpoints that were included and reported against in Masters1, versus Masters2? |
|
