At the point in time the trials were put together
Post# of 154867
(Total Views: 739)
Posted On: 03/30/2021 8:35:22 PM
Re: ClosetInvestor #84836
At the point in time the trials were put together s2c was much more of a death sentence than it was now however. This is when NYC was overrun with patients and they were triaging due to lack of equipment. I understand your argument that we didn't have 40 EIND patients to support our request but given the safety profile and the fact that we had given 4 doses to some if not all of the Montefiore patients, why would you, a regulatory authority, effectively ask for an m2m dosing regiment that was identical to the s2c regiment? That makes no sense to me and it obviously made no sense to Dr. Jay.
The only rationale I have is that the FDA still did not believe our MOA or the theory put forth by Dr. Patterson and therefore was erring on the side of being cautious? I dunno. Scratch that. It makes no sense to me still. Assuming what Dr. Jay said was true (and I have no reason to doubt him) then I cannot rationalize pushing us to have the same dosing between the two trials when we requested additional dosing for s2c. Given our safety profile, the half life of the drug and our MOA I am at a loss. I would be happy to hear their reasoning. If they didn't want to allow it because they wanted more patient data first, what were they hoping to understand that they didn't previously? That the "cytokine storm" was more severe in s2c than m2m???
Add it to the CYDY shareholder mystery bucket along with the additional requirements to get approval for HIV combo vis-a-vis mono, vis-a-vis RO tests. One day, all will be revealed, or not. More likely not. : -)
The only rationale I have is that the FDA still did not believe our MOA or the theory put forth by Dr. Patterson and therefore was erring on the side of being cautious? I dunno. Scratch that. It makes no sense to me still. Assuming what Dr. Jay said was true (and I have no reason to doubt him) then I cannot rationalize pushing us to have the same dosing between the two trials when we requested additional dosing for s2c. Given our safety profile, the half life of the drug and our MOA I am at a loss. I would be happy to hear their reasoning. If they didn't want to allow it because they wanted more patient data first, what were they hoping to understand that they didn't previously? That the "cytokine storm" was more severe in s2c than m2m???
Add it to the CYDY shareholder mystery bucket along with the additional requirements to get approval for HIV combo vis-a-vis mono, vis-a-vis RO tests. One day, all will be revealed, or not. More likely not. : -)
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