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Pharmboy46

11/02/20 11:39 AM

#2480 RE: GD #2479

This discussion reminds me of the discussion on the NWBO board. The discussion is centered around the FDA allowing historical controls when considering BLA submission. There has been plenty of indications recently where FDA has signaled this as a possibility. Bodes well for this trial as well!
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Fosco1

11/02/20 12:22 PM

#2481 RE: GD #2479

Oh yes
I am 80% sure, looking at IOMAB b results, that the FDA would accept change of the SAP plan, given the new orientations of FDA, you are citing OMER, and I have in mind as well NWBO and few others that might make it as well.
The only thing is I am not sure of the timing, so this Ph III might be delayed. Is it better to wait till completion with 100% of data or ask for early termination ? I am not sure what the company prefers, looks like the first option which makes me think they would prefer a normal completion to a lengthy talk. Company is not clear enough. I do not like lack of clarity and we know time is money while cash is burnt.