Thats two articles from Cynata explaining the FDA processes in 2023.
Suddenly the penny has dropped that the FDA is quite important wrt MSC’s. The TGA is waiting for the FDA, maybe? Because that would be a very good reason for Cynata to now start making noises that the OA (non FDA) P3 probably won’t be enough.
You see the OA trial is approximately at the point (I’m guessing because CYP aren’t providing any updates as to candidate enrolment) that overwhelming efficacy might come into play. Yesterday’s announcement tells us where that sits now. That’s new information.
Go back and read/watch all Ross’s comments on the OA trial and don’t stop until you find the parts about timing on the trial. Now apply this new information that there is probably going to be a need for another trial after the OA P3.
Oh this is new alright.
You should pay attention.
Talking about pennies (as above). Cynata can’t afford the paper clips for a FDA trial.
CYP needs cash and an office in the USA or someone to buy them to walk it like they talk it.
CYP Price at posting:
34.5¢ Sentiment: None Disclosure: Not Held
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