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A new video on youtube visualizing the function of NurOwn cells.
Hi XOV,
if i remember correctly, the compassionate use has to be separately approved on a patient-per-patient basis. The EAP allows for the treatment of all patients that are not eligible for the trial.
And as FDApproved already mentioned it looks as if government might pay for the treatment...?
It was updated a few seconds ago....interesting that the informations showed up earlier for you...
Hydroxychloroquine is no longer an option...
https://finance.yahoo.com/news/coronavirus-update-us-sees-steady-resurgence-as-fda-puts-nail-in-coffin-of-hydroxychloroquine-debate-184944215.html
Hi Skaye,
for Mesoblast, the FDA cleared the COVID trial on 06.04.2020. News on first patients treated was on 06.05.
Pluristem got the trial cleared on 08.05 and now the recruitment started (trial website says 04.06 for study start date). Timelines are comparable.
Athersys is a different thing, i would say because they already had their ARDS trial running.
from the beforementioned article:
These preliminary findings support the use of remdesivir for patients who are hospitalized with Covid-19 and require supplemental oxygen therapy. However, given high mortality despite the use of remdesivir, it is clear that treatment with an antiviral drug alone is not likely to be sufficient. Future strategies should evaluate antiviral agents in combination with other therapeutic approaches or combinations of antiviral agents to continue to improve patient outcomes in Covid-19.
https://www.nejm.org/doi/full/10.1056/NEJMoa2007764
Remdesivir is not enough...
https://www.health24.com/Medical/Infectious-diseases/Coronavirus/remdesivir-will-not-be-enough-to-curb-covid-19-study-finds-20200523
bad for the patients...good for Pluristem
Sorry, having problems to remember this correctly.
Can someone help me out here, please. What caused the delay in the CLI study/accelerated approval...sort of things. It was once said by the company that already 2018 might be the year of approval?
Additionally, where do i find any meaningful interims results/top-line data from the past CLI trials? The data seems to be pretty sparse.
Hi skitahoe,
don't forget that the 1 year interims data of the 50% enrolled CLI study patiens was due in April. Even though it was postponed, someone probably knows the outcome...
Hi FDA,
i hope you are right. We need those numbers. Scaling of production is crucial.
But don't get me wrong, i am very positive. And even 63 Bioreactors (they are not that big) divided among several production sites don't seem impossible to me.
At least it was said in the past the production facilities would suffice to produce 150.000 doses...
Yep...
20 billion cells per reactor in three weeks, thats 22 doses of 300 million cells per week giving us 1156 doses per year per reactor. For the 74.000 patients you need 63 reactors...?
i did some calculation for fun:
With estimated 190.000 ARDS cases in the US and a mortality of approx. 75.000 - only to treat those 75.000 patients Pluristem would need approx. 63 Bioreactors of the old standard type (with 300 million cells per treatment). This would bring them a revenue of 1.5 Billion Dollars (20.000 Dollars per treatment?). Estimating a 15% profit margin this would equal a profit per shar of 10 Dollars.
With a P/E of lets say 60? this is 590 Dollars per share.
Where is my mistake? Is there one?
Your thoughts...
Pursuant to ASX Listing Rule 17.1, Mesoblast Limited ACN 109 431 870 (ASX: MSB; NASDAQ:
MESO) (the Company) requests a trading halt in its securities effective immediately pending an
announcement by the Company in relation to a proposed equity financing.
http://investorsmedia.mesoblast.com/asx-announcements
Very positive article:
https://www.painnewsnetwork.org/stories/2020/5/11/the-fdas-stem-cell-reformation-must-proceed-beyond-covid-19
The COVID-19 crisis has been a catalyst for new regulatory flexibility at the U.S. Food and Drug Administration. The FDA is pushing aggressively to develop new vaccines and treatments for coronavirus, including dozens of clinical trials of stem cell therapies on critically ill patients.
...A stem cell reformation of sorts is underway at the FDA due to the coronavirus pandemic.
...The FDA's current push for stem cell innovation must proceed beyond the therapeutic necessity of coronavirus.
GLTA
Hi FDApproved,
Athersys had separate announcements for approval and initiation of their study as well as for commencement of enrollment.
Do you think Pluristem will immediately start treatment of patiens in the scope of the study or do we also have to wait for those announcements first?
BR
First of all congratulations to this immensely important milestone.
I principally agree with you, emit, on the questionableness of a placebo affect on an unconscious patient. Especially when the differences between real treatment and placebo are as dramatic as we expect.
Nevertheless i would like to stress the point of a DOUBLE blinded study which implies, that also the doctor who applies the drug does not know if its the real thing or the placebo. And this indeed can make a difference.
Intentional or not, the medical personnel might give a little more attention to the patient who received the real thing...
GLTA
...impressive summary....
i'm positive....ehm...euphoric.
GLTA
New webpage summarizing Pluristem activities:
http://www.centrostudipbvpartners.com/os_client_feed.asp?cln=38261915
A little sparse at the moment but might be helpful in the future.
GLTA
Snippet from this site: http://www.china.org.cn/world/Off_the_Wire/2020-05/06/content_76009623.htm
"The success has been widely reported. Yanay revealed that his company receives hundreds of applications a day from the patients, families and doctors who hope to try the therapy in an attempt to save lives."
Not sure whether the number of daily applications was already mentioned somewhere.
Sounds promising.
Nice! Mesoblast, Athersys and Pluristem mentioned in Forbes article.
Link:
https://www.forbes.com/sites/alexknapp/2020/05/02/large-scale-clinical-trials-of-mesoblasts-stem-cell-treatment-for-covid-19-coronavirus-set-to-begin-soon/#70e7ecb24086
Nice, Mesoblast, Athersys and Pluristem mentioned in Forbes article.
Link:
https://www.forbes.com/sites/alexknapp/2020/05/02/large-scale-clinical-trials-of-mesoblasts-stem-cell-treatment-for-covid-19-coronavirus-set-to-begin-soon/#70e7ecb24086
Hello to everyone. First of all many thanks to all the posters on this board. Much valuable information.
I'm new to this board but not new to Pluristem. Already invested for several years and pretty excited about the recent COVID dynamics.
I'm coming from the Biology/Pharma world and this UV story is so ridiculous IMO that it pushed me to write my first post.
IMO there are huge indications that stem cells could cure COVID-19 but i highly doubt that UV light administered to the inside of your lungs could do so.
I'll be sticking with Pluristem.
GLA