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Friday, 07/09/2021 9:55:28 AM

Friday, July 09, 2021 9:55:28 AM

Post# of 43841
I saw this a while back from @GD concerning BLA Filing, pay attention to the parts referring to the filing & I'm not sure about "meeting the primary endpoint"....since I think we are looking at the secondary endpoint?

I would think that John Cipriano, SVP would know, since he is the person speaking with the FDA & potentially with Big Pharma:


"It is too early to talk about BLA, here is the steps:
1 Get the trial pass the primary endpoint FIRST!!!!!
2 Present the data at major cancer conference(2 to 3 month)
3 Meet the FDA for BLA plan meeting to agree what needed for CMC and data(3 month time)
3 File the BLA(normal 6 month)
4 FDA accepting BAL (2 month)
6 FDA priority review and approval(6 month)
Step 2 and 3 are going at the same time
Added 140 Feb 35 calls for 60 cents/share today, I like the
risk/reward ratio!"

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