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Posted On: 05/04/2023 12:32:20 PM
Post# of 148892
It shouldn't take 4-5 months to submit the protocol and get a 30 day response from the FDA. We already have experience with submitting HIV protocols that were subsequently approved by the FDA, and I have to assume we'll take what we've previously submitted and tweak it. I can't imagine that taking more than a month, but again, I'm just speculating (sorry, Craig).
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I'm convinced we'll get there. but if I had to guess, i think it will be late in the Summer (or even early Fall) until everything is submitted, and we get a response from the FDA.
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My comments are just my opinions and should NOT be taken as investment advice.
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