Initial BLA submission- Pre end of the world covid pandemic- Company share price circa $3.00 536,000,000 shares on issue 1.6 Billion valuation
We are close to the 2020 valuation, another 20 cents to go
Talk about being knocked around by Covid and a couple of Complete Response Letters ( fair enough).
The significance of directors buying on market recently should not be underestimated- nil purchased 2019.
Straight after the initial BLA submission we get told it works in Chronic - off label sales anyone?
Medical professionals vote that Ryoncil is safe and efficacious
Professor Kurtzberg for the win , linking in vivo biomarkers to good old survival outcomes
Pipeline product durable three year pain reduction results
Novartis would not have been impressed with this one
Pipeline for back pain gets a leg up
CHF results published
Notified no form 483 issued so Ryoncil manufacturing is signed off by the FDA - how is the price lower than 2020???????????????????????
Possible 100 million dollar voucher - that will be nice to pay for stock manufacturing
100% successful- small trial- but we are definitely on the FDA radar
Probably the biggest highlight on this page- pathway to Global Partnership- my view
Back to refiling the BLA
After 4 years of setbacks we are back on track.
For the newbies, the pipeline has not increased in valuation- Ryoncil has been substantially derisked with manufacturing sign off, survival results and apparent agreement on potency related issues to allow for refiling of the SR aGvHD pediatric BLA.
The hype was either parabolic back in Feb 2020 or the market is pricing it wrong today.
I'm biased as am a holder. Still, I review, recheck, drink and sleep.
My mind is running a repetitive loop.
Phil Krause saying trial showed efficacy - need to prove potency,
@JB1975 saying issues with small n and too many confounding variables like different medical professionals administering different treatments ( sorry jb my understanding- not direct quotes), Si saying we couldn't do a new trial until potency assays approved. New trial being partnered with CIBMTR, advised funded etc. Then the company meets with the FDA and reverts to original plan. Asefficacy was signalled in pediatric, then yes, it is unethical to run another pediatric trial.
To stop the loop
My mind says - if efficacy is proven, then JB's points re small n and confounding variables are no longer valid , in terms of getting approved.
If the adult trial is on hold, then there is agreement that the 001 pediatric data may be enough to get approval.
Potency must be proven,imo, in the 001 trial product- as no further trials ( review process) were to occur until agreement or else why would the review be back on?
The announcement to refile specifically said after additional consideration of the data from the 001 study- not any other part of the BLA submission.
Happy to have a conversation re my loopiness- please point out faults in my supposed logic- might have a few bucks on the line here
How are we under Feb 2020 valuation?
Reg (The Bemused)
(20min delay)