As per my previous post:
Definitely very early, but this is encouraging news for CYYNF.
We have (preliminary) data for 6 disease targets:
- CLI
- GvHD
- Asthma
- Glioblastoma
- Myocardial Infarction (due any day now)
- ARDS (due any day now)
So far, only one of them has progressed to to a clinical trial, with results only half way in.
No definitive agreement signed and apart from a nominal payment from apceth, no actual licence fee has been received, hence we are still at $1.50 at this stage.
It's "very early" in the game, given that Cymerus is a platform that can address shortcomings in as many as 650 currently registered clinical trials, spread over way more than just 6 disease targets, and new ones being added almost daily.
The key to unlock the potential was safety:
"We are looking at safety issues, but MSCs are already proven to be safe. At 28 days post-injection, if the patients are sitting up in bed or walking around, the product will have worked."
https://www.streetwisereports.com/a...ey-stewart-washer-of-cynata-therapeutics.html
And CYP-001 did not just prove safety, it also delivered efficacy results, that have not been seen before. And all that at a fraction of the cost of current MSC products (including the ones currently being developed).
Apceth, FujiFilm and Celularity are only the beginning. Plenty of disease targets out there, including the possibility to issue more than one licence per target (CYP-001 is our MSC product for GvHD only, it's not the disease target itself...).
Orphan drug designation is great, it comes with a few perks that will come in handy for FujiFilm, I'm sure.
However, I have a suspicion that there are more FDA news coming very soon, given the comments made to The Chemical Daily - RMAT!
https://hotcopper.com.au/threads/cy...4040824/page-89?post_id=31366642#.WsHHUHMRWdM
"The RMAT designation makes therapies eligible for the same actions to expedite the development and review of a marketing application that are available to drugs that receive breakthrough therapy designation – including increased meeting opportunities, early interactions to discuss any potential surrogate or intermediate endpoints and the potential to support accelerated approval."
https://globenewswire.com/news-rele...-for-Duchenne-Muscular-Dystrophy-Therapy.html
Anyways, $1.50 is only the starting point for the next leg up. Just give it some time for all the pieces to fall in place
