It looks to me like Azer-cel will be the first to go for the FDA approval given that all the ducks are lined up with fast track and in an unmet need..
Possibly receiving another 3-4 patients worth of data and maintaing a 55-60% CR rate with a 6 month duration will be enough for an accelerated approval, this remains to be seen.
OnCARlytics may seek approval in another jurisdiction which would spread the risk out a bit more and not depend on the FDA for the whole show.
Regardless of where approval is sought, Leslie is definitely showing more confidence in how CF33 is performing in both the MAST & OASIS trials, we have importantly established safety and efficacy at lower doses, Yuman is confident that as OBD is established the results will only get more emphatic with possibly further types of cancer being tackled, e.g. Melanoma & Mesothelioma.
And although not currently set as a priority the B-cell platform is still on the books for sale with comparable results to Keytruda and an improved safety profile.
News is on the way and if I could spare more dollars, (already getting nose bleeds from my current level of investment), I would be soaking up more at these levels, particularly the oppies at .011, how ridiculous is that? Sitting at nearly a third of the price of the heads.
DYOR opinion only
IMU Price at posting:
3.3¢ Sentiment: Buy Disclosure: Held
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