athx1
New Member
Posts: 7
|
Post by athx1 on Mar 23, 2020 0:18:27 GMT
I just signed up for biotech. How do I find current posts. I only start at 2014. Thanks
Ok I found what I was looking for.
|
|
athx1
New Member
Posts: 7
|
Post by athx1 on Mar 23, 2020 0:28:48 GMT
I expected a good week ahead however Congress vote failed.
Athx has a very reasonable shot of getting BARDA money for the value MultiStem keeping ARDS pneumonia off ventilators and out of the ICU.
Will be an interesting week.
|
|
|
|
Post by selluwud on Mar 23, 2020 12:53:27 GMT
Market liking recent FDA news to push therapeutics for Covid-19. ATHX in the pole position to treat the most severe cases that degrade into ARDS. ATHX/BARDA agreement coming soon which will include non-dilutive $$$ and will better define the path ahead. In response to some private messages from some not following Athersys (ATHX), below is a summary of the current situation and opportunity given the Covid-19 pandemic, from my perspective. My intent with this post is to frame things in a way that allows folks unfamiliar with ATHX to digest relevant information relatively quickly, including the near-term opportunity and risks. I've provided some links in the appendix so anyone can drill down as much as they'd like. Good luck all.
Quick Summary:
Acute Respiratory Distress Syndrome (ARDS) is the leading cause of death among Covid-19 infected patients. Athersys' MultiStem cell therapy is focused on this "critical care" market segment, has completed a Phase 2 clinical trial for ARDS with very promising results, and is the only company with Fast Track designation from the FDA for ARDS. While MultiStem is not approved for commercial use, the US Government (BARDA) is currently actively engaged with Athersys leadership to advance the MultiStem therapy as "quickly as possible", and has deemed MultiStem "Highly Relevant" to the Covid-19 outbreak. News on the path forward from Athersys/BARDA is expected at any time.
Given the urgent need which is a matter of life or death for critically afflicted patients, an important question is "How quick will the FDA & BARDA move?"
The Big Picture - Situation Analysis:
While ATHX has a deep clinical pipeline (ARDS, stroke, trauma, etc), this summary will focus on ARDS (Acute Respiratory Distress Syndrome) as the global Covid-19 pandemic has pushed that program to the forefront.
In summary, the world is racing to medically address the Covid-19 pandemic in 3 major ways, from my perspective:
Vaccines - The first "line of defense" are vaccines which aim to prevent infections, but won't be ready for 12-18 months.
Anti-Viral Treatments - Once infected, the second line of defense are anti-virals to treat the infection. Last week the FDA announced some good news where a few existing FDA approved anti-virals (approved for other diseases), are being re-purposed to treat Covid-19 patients, and evaluate their effectiveness. Per Dr. Fauci, their effectiveness against Covid-19 has not been proved.
Critical Care for Patients that Degrade and Develop ARDS / Moved to ICU and Placed on Ventilators - Even if the anti-virals and eventually vaccines have some success, a "meaningful number of people" per the Athersys CEO, will still degrade and develop ARDs. For these ARDS patients that require critical respiratory care, there are no FDA approved treatments, as the current standard of care is severely lacking and consists of placement in an ICU bed (if one is available), ventilator support (if one is available), and hope for the best. Death is a frequent outcome, and patients that survive face a difficult road to recovery as in many cases, the impacts are permanent. Treatments beyond ventilator support for the critical care patients are needed, now.
The urgency of new critical care treatments is amplified given the huge spikes in the number of patients due to Covid-19. Over the past several months we've seen China build new hospitals to attempt to meet the surge in demand. We continue to see and hear the stories of hospitals and ICUs being over-run with Covid-19 patients that are having severe respiratory issues, and are in urgent need of ICU beds and ventilators. In some cases (Italy) the physicians are making life/death decisions on who gets an ICU bed and ventilator, and who doesn't.
For COVID-19 infected Patients, ARDS is the Leading Cause of Death - According to a recent World Health Organization analysis and other clinical and epidemiological data, ARDS is the leading cause of death among COVID-19 infected patients. (Appendix - Slide #34 of Athersys Corporate Presentation)
With the global pandemic raging, is there anything out there that can help critically ill patients with severe respiratory failure needing ICU and ventilation support?
Yes, there is... but the therapy is not approved by the FDA, yet.
The Athersys Critical Care/ARDS Treatment and Clinical Trial Results: Athersys has the only ARDS treatment with Fast-Track designation by the FDA. The treatment completed a Phase 2 trial in the United States with a Phase 3 trial to start soon, and a pivotal trial is nearing completion in Japan.
As someone who has followed Athersys and their MultiStem treatment for close to a decade, its frustrating (and sad) not to see any national news discussions of their very promising MultiStem cell therapy for these critical care ARDs patients. However, due to the Covid-19 pandemic, it appears that Athersys now has the attention at the highest levels within the United States government (see BARDA link in Appendix), and they're working together to advance the program as "quickly as possible", per the Athersys CEO.
Why Do Some People Get ARDS? - After infected with Covid-19, "a pulmonary hyper-inflammatory response can occur, leading to severe pulmonary dysfunction & hospitalization". (Appendix - Slide #39 of Athersys Corporate Presentation) How does MultiStem treat ARDS? - Essentially, MultiStem helps regulate the immune system, so the hyper-inflammatory response is mitigated.
MultiStem has shown very promising Phase 2 clinical trial results, with initial 28 day and longer term 1-year follow-up data reported. A Phase 3 trial is planned in the United States, and an open-label pivotal trial is on-going and nearing completion in Japan. Some key points from the Phase 2 data is below, which is for patients with "low pulmonary function at baseline", who may be the most at risk to develop complications. (Appendix - Slides #37 and #39 of Athersys Corporate Presentation):
Saved Lives - Mortality MultiStem 25% / Mortality Placebo 50% (Half as many of the MultiStem treated patients died compared to placebo.)
ICU Capacity Increased - ICU Free Days MultiStem 11.4 / ICU Free Days Placebo 5.9 (Almost half less time in ICU.)
Ventilator Capacity Increased - Ventilator Free Days MultiStem 14.6 / Ventilator Free Days Placebo 8 (Almost half less time on Ventilator.) Improved Quality of Life at 1 Year - 80% of surviving patients in MultiStem group achieved complete independence in self-care vs. 40% in placebo group
In summary, albeit a Phase 2 trial with a small data-set, Athersys' MultiStem therapy directly addressed the urgent needs of critical care patients and hospital ICU and ventilator capacity. One can easily extrapolate the above results to the current situation, and see the potential to save many lives and increase hospital capacity.
MultiStem also has an excellent safety profile as a result of 10 clinical trials conducted over 12 years where safety has been established in 6 different disease indications, for approximately 1000 trial participants, including placebo. Potential benefits are substantial, including life versus death, and far exceed any risks, in my view. So, what are we waiting for as the pandemic continues to kill and shuts down the world? That brings us to the path forward, where the highest level of the United State government now appears actively engaged.
The Path Forward:
The Path Forward - Background: Per the Athersys CEO in the 3/16/2020 press release (see appendix), here's what he stated about their ARDS program, and how its being advanced in-light of the Covid-19 outbreak, in partnership with the US Government and BARDA: (See appendix for BARDA information.)
“The importance of this program has been reinforced by the recent COVID-19 outbreak, where many patients have subsequently become critically ill with ARDS, which a recent World Health Organization analysis has confirmed is the primary cause of death for these patients. This often fatal syndrome can be induced by a range of pathogens, including COVID-19, SARS, MERS and virulent influenza.
“Other than placing patients on a ventilator, there is no effective treatment for ARDS. In January, in the early stages of the COVID-19 outbreak, as part of the U.S. Government's COVID-19 CoronaWatch program, we were approached by BARDA in its leadership role focused on expediting diagnostics, vaccines, antivirals and therapeutic treatments for these patients. After undergoing multiple reviews, we are pleased to announce that MultiStem® was designated as a “Highly Relevant” therapeutic for COVID-19 by BARDA. We now are working to expedite the further advancement of the program, which has also shown relevance to certain other areas of interest for BARDA,” added Dr. Van Bokkelen.
The Path Forward - Finalization of Athersys/BARDA Collaboration Agreement:
Per the CEO in the 3/16/2020 press release (appendix), the agreement with BARDA is being "finalized". The CEO stated “We remain highly focused on achieving our core goals and are making excellent progress. Our near-term priorities are to finalize and implement an alliance with BARDA, establish a high value collaboration around our critical care programs, and continue to advance our clinical programs, while we add additional talent and leadership to the organization and expand our capabilities,” concluded Dr. Van Bokkelen.
The Path Forward - Hints of a Broader Collaboration with BARDA, Beyond Covid-19:
Subsequent comments by the CEO have hinted at perhaps a broader collaboration with BARDA, beyond just Covid-19 impacts. The CEO noted that when new pathogens emerge (i.e. SARS, MERS, Covid-19, etc.) the world is always behind the curve racing to develop new vaccines & new anti-virals for the next illness. He notes that MultiStem could be a valuable treatment tool in the national arsenal, as it treats impacted patients with ARDS regardless of the current or future pathogen causing the illness. We're in wait-and-see mode to see what the BARDA collaboration agreement may or may not include, on this interesting and forward looking concept.
The Path Forward - Will it be Bold Enough for those with Covid-19 induced ARDS, Fighting for their Lives on a Ventilator Today? The FDA Commissioner recently stated his goal of making safe and effective therapies available to Covid-19 patients in need, as quickly as possible. Until I see the ATHX/BARDA collaboration agreement, I'm not going to pass any judgements on whether the path forward is bold enough, and whether it matches the urgency needed by patients on a ventilator who are fighting for their lives at this very moment, and the new patients who will certainly be fighting for their lives in the weeks ahead. I'll just say that MultiStem has an established safety record, and will let Jason Kolbert make the case for the FDA to immediately approve MultiStem via Emergency Authorization Use (EAU) for patients in need. Please see the appendix for Jason's TV interview.
Regardless of what the ATHX/BARDA agreement contains, I commend the Athersys CEO and management team for advancing the ARDS program over the past many years, as they recognized the importance of their treatment, and have brought it to the brink of being deployed to help thousands, perhaps hundreds of thousands of people.
Large ARDS Market Opportunity:
ARDS is not just caused by Covid-19, and afflicts approximately 500,000 patients in Europe, the United States and Japan combined annually.
An outbreak of highly infectious pathogens (e.g. SARS, Coronavirus, Influenza) that result in severe acute pulmonary disease could cause a surge in ARDS incidence.
No effective pharmaceutical or biologic treatments currently available.
Represents a multi-billion $ market opportunity.
Note: The above does not discuss Athersys even larger target markets for stroke and trauma, which are also advancing.
Major Upcoming Milestones:
Below are what I consider some major upcoming milestones I'm tracking for both the ARDS and stroke programs, which I expect to see through the remainder of 2020 and early 2021:
- Any Day - ATHX/BARDA Collaboration Agreement Announced. (Latest CEO guidance is that the agreement is being "finalized".)
- April/May - ARDS Peer-Reviewed Data Publication (Given the pandemic, this publication could have an impact. Intent to publish was noted via PR in January 2020.)
- May - ARDS Japan/Helios Trial Enrollment Completion (Helios Board member indicated May completion target at recent panel discussion.)
- June/July/August - ARDS Pivotal Trial Data Announced (Trial endpoint data is gathered 28 days after patient enrollment.)
- June/July/August - European Partnership (IMO this can come at any time, but management may feel they'll be in a stronger position to sign a deal after the Japan ARDS data is made public. Pros and cons can be argued for either approach. I have high confidence the Athersys team will maximize value.)
- September - Stroke Trial Enrollment Completion in Japan (Helios Board member indicated Sept completion target at recent panel discussion.)
- December/January - Stroke Data Japan (Stroke data expected 90-120 days after enrollment completion.)
- Any Day WILDCARD - Emergency Use Authorization (EAU) issued by FDA for MultiStem to Allow Treatments to Begin Now Based on Phase 2 Data (We can all dream.)
In some years, with lengthy clinical trials in progress there can sometimes be a news drought. 2020 is NOT one of those years.
The Risks: I hold a position in ATHX and intend to continue to hold, as I believe many value-creating milestones will unfold in 2020. However, anyone thinking of investing or increasing their position should note that biotech stocks are high-risk investments. While many risks exist, some of the key near-term risks on my radar that I monitor and continually re-assess are listed and briefly discussed below.
Risk that the Pending ATHX/BARDA Agreement Does Not Meet Market Expectations - The stock has run-up 50% over the past week from approximately $1.20 to $1.80 (March 16th to March 20th). In my opinion (IMO), at least part of this run-up is due to the market's expectation of a significant collaboration agreement with BARDA to address Covid-19. If the agreement - when announced - does not meet market expectations (in terms of funding, schedule and scope), the stock could retrace.
Is this Risk Mitigated? In my opinion, because the MultiStem therapy has a stellar safety profile, has been designated as "Highly Relevant" by BARDA, and is the only treatment for ARDS with Fast-Track designation by the FDA, I believe the MultiStem therapy will be adequately funded by BARDA to quickly advance the program to treat Covid-19 patients in need. A legitimate question is, how quick? I believe the pending ATHX/BARDA collaboration agreement will reflect the urgent needs of patients and hospital capacity.... and will reflect the dire consequences of anything less than bold action. So, I'm expecting a significant/beefy deal with BARDA, and believe the market will like what it hears. (As always, the above is my opinion. I could be wrong.)
Risk of Low Cash Position - Per their SEC filings, Athersys cash position at 12/31/2019 was approximately $35 million. They burn approximately $12 million per quarter, so by 3/31/2020 they'll have approximately $23 million in cash, plus any cash raised via their equity line with Aspire. Cash needs will increase in 2020, per SEC filings. Is this Risk Mitigated? In my opinion, the following pending activities will provide ample cash: 1) BARDA agreement - While this agreement will likely allocate funds to the ARDS program only and not general corporate needs, it should - combined with the Aspire equity line - provide an ample bridge to their next major source of cash which is, 2) European Partnership - Guidance from Athersys via slide #42 of the corporate presentation (see appendix) is "Complete evaluation / implementation of key partnering initiatives", which implies they expect a deal done before the end of 2020, so that it can be "implemented" before year end 2020. In my view, the pending BARDA agreement will create more partner interest and perhaps competition to be Athersys' partner in Europe. Lastly and in the worst case, if they feel they need to raise capital via an equity offering (dilution) before the European partnership produces cash, I'm reasonably comfortable that the BARDA agreement will cause the stock price to find a higher new floor, so that modest dilution - if needed - will bridge them to closure of the European partnership later in 2020.
Risk from Competition - Given the urgent need, there's a competitive race to find vaccines, anti-virals and therapies. Is this Risk Mitigated? Even with eventual upstream success with vaccines and anti-virals, there will always be a need for therapies in the critical care segment for ARDS. To the CEO's knowledge, Athersys is the only company with a therapy designated as Fast-Track by the FDA for ARDS. In my view, that designation serves to mitigate this risk. The fact that BARDA approached Athersys to explore ways to accelerate their ARDS timelines appears to indicate that Athersys is at the forefront. I'm going to re-assess this risk after I see the ATHX/BARDA collaboration agreement, as that agreement should let us know how quickly the MultiStem treatment will move forward. The faster Athersys, BARDA and the FDA work together to get MultiStem approved for ARDS, the more this risk will be mitigated.
Risk that soon to be released pivotal trial ARDS data from Helios (Athersys' partner in Japan) is not favorable - Data from Helios' pivotal trial treating ARDS patients with MultiStem will likely be released sometime this summer. Like all biotechnology companies, if clinical data is not positive it usually has a severe negative impact. Is this Risk Mitigated? In my view, this risk is mitigated in 3 ways: 1) The new Japanese regenerative medicine laws allow therapies to be either approved or conditionally approved based on signs of efficacy. All trial endpoints do not have to be met in order to achieve conditional approval. In my opinion, given prior trial results, biomarker analysis, and the well understood mechanism of action with MultiStem, there is a high probability that at least some signs of efficacy will be observed to allow conditional approval, at a minimum. 2) BARDA just recently gave MultiStem the "Highly Relevant" designation in the 1st quarter of this year. Before giving this designation, BARDA took a detailed look at MultiStem, which - in my opinion - included a review of all available clinical data. Since Helios' ARDS trial is open-label (meaning data is available for Helios to review) it most likely included a review of that data, as Helios and Athersys are partners. In my opinion, BARDA would not have given the "Highly Relevant" designation if the open-label data was poor. 3) At a recent company presentation, the CEO of Helios expressed confidence that the MultiStem therapy would be approved. In my view, with an open-label trial, confidence would only be expressed if the data was promising.
Conclusion: MultiStem has established an excellent safety record over an approximate 12 year period, in 10 clinical trials, for 6 different diseases, which included approximately 1000 trial patients, including placebo. (Source is clinicaltrials.gov in Appendix). The MultiStem cells do not engraft and are cleared from the body in days.
With significant efficacy reported in their Phase 2 ARDS trial, it would seem that invoking Emergency Authorization Use (EAU) for MultiStem would provide a low risk approach to give severely afflicted ARDS patients a fighting chance, while also helping address the shortage of critical care resources; ICU beds and ventilators.
Athersys is a small biotechnology company with 75 employees and a relatively small valuation of $300 million. Given the on-going pandemic, Athersys' promising MultiStem therapy to treat severely afflicted ARDS patients, and active US government/BARDA engagement with some level of funding pending and imminent, I consider it under-valued at current levels of approximately $2.00 per share.
If MultiStem is not given Emergency Authorization Use (EAU) for ARDS sometime this coming week, my next post will be the letter I send to my local and State politicians, to attempt to raise awareness and push from the bottom up.
Appendix/Links:
What is ARDS? (ATHX Video)
Plea to Allow Emergency Authorization Use (EAU) for MultiStem - Jason Kolbert Analyst Interview
Athersys Corporate Presentation (March 2020)
US Government BARDA Mission (BARDA Website)
03/16/2020 Press Release - CEO Comments - "Highly Relevant" BARDA Designation & Pending BARDA Agreement
Wall Street Titan (WST) Article on Seeking Alpha. WST is a knowledgeable biotech analyst and long-time Athersys advocate, who consistently provides well-researched articles, interviews and other content on Athersys and other biotechnology companies. This article - like all his others - is worth a read.
You've laid it out very nicely jckrdu, If ATHX's therapy/procedure is everything we've been led to believe, I don't see how it can be overlooked as the only viable way to lessen the deaths by ARDS. The standard of care is not very impressive and the safety profile has long been established. Only politics or greed could stand in the way of conditional use and approval, let's hope this doesn't get trivialized and left behind. |
|
|
|
Post by jckrdu on Mar 23, 2020 14:37:38 GMT
Thanks all. Hopefully the recent write-up is useful to let others know about the opportunity here.
Nice consolidation over $1.75.
My crystal ball says we keep grinding higher into the $2.00 - $2.25 range (recent highs) before BARDA news is announced.
From there, we either go higher if BARDA news is significant (sizeable funding, expedited schedules), or retrace if its not.
GL all.
|
|
|
|
Post by tmfbmf on Mar 23, 2020 20:34:33 GMT
I sent this email to IR about an Athersys patent issued 3/10. Karen emailed me her response. The patent is long but definitely worth a read. Basically, we have a patent on modifying MAPCs so we can now tailor them to address any inefficiencies we see with the current trials. Per Karen's response, this may entail completing new clinical trials with the modified cells. --- Hi Karen. I saw this new patent issued. It looks like it holds amazing opportunities for the company. I have a question about it. If we alter the MAPCs for a more robust treatment, will we have to do a whole new line of trials? Or would the FDA deem the MAPCs and the modified MAPCs similar enough to only require a post-market Phase IV study for efficacy? Thanks! patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&d=PTXT&s1=%22ABT+Holding%22&OS=%22ABT+Holding%22&RS=%22ABT+Holding%22--- This patent does have the potential to cover new opportunities for the company for next generation or follow-up products, though we are currently focused on advancement of our MultiStem® product to approval. Ultimately, we would have to work with the FDA to determine the appropriate development path for any new or improved product applying this technology application. Best Regards, Karen |
|
|
|
Post by jckrdu on Mar 23, 2020 20:40:30 GMT
Thanks all. Hopefully the recent write-up is useful to let others know about the opportunity here. Nice consolidation over $1.75. My crystal ball says we keep grinding higher into the $2.00 - $2.25 range (recent highs) before BARDA news is announced. From there, we either go higher if BARDA news is significant (sizeable funding, expedited schedules), or retrace if its not. GL all. Nice close right under $2. Not expecting too much more from here until BARDA news... maybe we grind a little higher into the $2.00 - $2.25 range per my post above from this morning, until BARDA news. I just don't see a lot of selling pressure until that news, as many know its coming.
After announced, I (and IMO the market) will be looking at the BARDA news thru the lens of the following questions to get a sense of how significant it is. The more of the below boxes that are checked off, the higher ATHX can move up and be re-valued at a higher market cap with the US Gov behind it. The less boxes that are checked, the greater a chance for a "sell the news" effect.
1. Funding Amount - Does the agreement include at least $50M+ funding? (Approximate 1 Year cash burn)
2. Schedule Defined - Is the time-frame for the ARDS/Covid19 arm in the trial defined? Firm Start Date established?
3. Scope / Covid-19 Current Outbreak - Will Covid19 patients affected by the current outbreak be treated over the next 2-4 months? (Market can then expect data.)
4. Scope / Manufacturing Scale-up in Parallel - Does the agreement speak to manufacturing support to scale-up commercial production in parallel?
5. Scope / National Stockpile Path - Does the agreement include options/path to include supplying a national stockpile of MultiStem?
6. Revenue - Early Use Funding - Does the agreement include funding for either Emergency Auth Use or Compassionate Use treatment now?
If we do get a "sell the news" effect on a weaker than expected BARDA deal (low funding amount / nebulous schedule... and nothing on #3,4,5 and 6 above), IMO ATHX will still find a decent floor and eventually trend higher as we approach the next set of milestones, which are coming soon.
|
|
|
|
Post by CM kipper007 on Mar 26, 2020 2:58:18 GMT
www.reddit.com/r/ATHX/comments/fois1z/letter_to_pence_from_ohio_congressmen/So the letter to Pence was interesting, but at the end of the day, this was just a letter. And I know things don't happen over night. Does anyone know how much clout a letter like that carries? Meaning from the people that sent it? Are Brown and Portman respected etc.? Is there any sort of procedure that says a letter from Ohio Delegation require a response or some review of the details?
|
|
|
|
Post by selluwud on Mar 26, 2020 11:48:32 GMT
www.reddit.com/r/ATHX/comments/fois1z/letter_to_pence_from_ohio_congressmen/So the letter to Pence was interesting, but at the end of the day, this was just a letter. And I know things don't happen over night. Does anyone know how much clout a letter like that carries? Meaning from the people that sent it? Are Brown and Portman respected etc.? Is there any sort of procedure that says a letter from Ohio Delegation require a response or some review of the details? Hopefully, smart & logical thinking will prevail and not politics as usual. |
|
|
|
Post by CM kipper007 on Mar 26, 2020 15:13:09 GMT
www.reddit.com/r/ATHX/comments/fois1z/letter_to_pence_from_ohio_congressmen/So the letter to Pence was interesting, but at the end of the day, this was just a letter. And I know things don't happen over night. Does anyone know how much clout a letter like that carries? Meaning from the people that sent it? Are Brown and Portman respected etc.? Is there any sort of procedure that says a letter from Ohio Delegation require a response or some review of the details? Hopefully, smart & logical thinking will prevail and not politics as usual. Hoping so. I read one location in the states is at ICU capacity already. If MS does work, they need it to free up those beds and machines. |
|
|
|
Post by jckrdu on Mar 26, 2020 17:05:37 GMT
Hopefully, smart & logical thinking will prevail and not politics as usual. Hoping so. I read one location in the states is at ICU capacity already. If MS does work, they need it to free up those beds and machines. I thought that letter would have had much more of an immediate impact. It didn't. My thinking was that the market would interpret high-level political support as eventually translating into financial support (and buying pressure would increase), but the market didn't make that connection, yet. |
|
|
|
Post by selluwud on Mar 26, 2020 17:26:39 GMT
Hoping so. I read one location in the states is at ICU capacity already. If MS does work, they need it to free up those beds and machines. I thought that letter would have had much more of an immediate impact. It didn't. My thinking was that the market would interpret high-level political support as eventually translating into financial support (and buying pressure would increase), but the market didn't make that connection, yet. The FDA is full of such pragmatic, scientific protocol, rule following sticklers that it would take an act of congress to get them to budge. The old thalidomide catastrophe still weighs on their collective consciences. |
|
|
|
Post by jckrdu on Mar 26, 2020 18:27:52 GMT
I thought that letter would have had much more of an immediate impact. It didn't. My thinking was that the market would interpret high-level political support as eventually translating into financial support (and buying pressure would increase), but the market didn't make that connection, yet. The FDA is full of such pragmatic, scientific protocol, rule following sticklers that it would take an act of congress to get them to budge. The old thalidomide catastrophe still weighs on their collective consciences. Agree. Only thing I'd add is that the Portman letter is a potential catalyst that could easily propel Athersys into the national discussion, with everyone looking for therapies. Could easily see a reporter getting a hold of that letter and interviewing Portman (or anyone from the delegation that sent the letter), and ask him who the company is that was referenced. That could generate national discussion of Athersys - IMO - and would likely generate some significant buying pressure. |
|
|
|
Post by selluwud on Mar 26, 2020 18:55:29 GMT
The FDA is full of such pragmatic, scientific protocol, rule following sticklers that it would take an act of congress to get them to budge. The old thalidomide catastrophe still weighs on their collective consciences. Agree. Only thing I'd add is that the Portman letter is a potential catalyst that could easily propel Athersys into the national discussion, with everyone looking for therapies. Could easily see a reporter getting a hold of that letter and interviewing Portman (or anyone from the delegation that sent the letter), and ask him who the company is that was referenced. That could generate national discussion of Athersys - IMO - and would likely generate some significant buying pressure. Without being too glib, as the fatalities from the COV-19 increase, the need to treat ARDS will become that much more urgent and morally expedient of extreme measures regardless the risk that "Scientist/Doctors" are willing to take. |
|
|
|
Post by CM kipper007 on Mar 27, 2020 18:31:30 GMT
Hoping so. I read one location in the states is at ICU capacity already. If MS does work, they need it to free up those beds and machines. I thought that letter would have had much more of an immediate impact. It didn't. My thinking was that the market would interpret high-level political support as eventually translating into financial support (and buying pressure would increase), but the market didn't make that connection, yet. Maybe it's happening now? |
|
Good to remember this place is here, saw your post on Reddit
