Developing the algorithm or peptide chain is very
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Posted On: 11/18/2020 12:49:37 PM
Developing the algorithm or peptide chain is very important work + the credibility that Epivax has established with the FDA by becoming the chosen platform by the FDA for doing this goes to provide excellent validity fir the decisions that GNBT/NGIO has made. We found them and engaged before everyone else.
As for the timing, I attribute our differences in educated guessing to pessimism v optimism. First quarter trial = January 15th to me, to you it means March 31st. I’m just judging by the timeline from others it took others 3-4 months to trial August through Oct/Nov. Two to three more to gain clearance. If regulatory clearances in OUS countries are concurrently happening (which they should be) and combining emergent use cases, it could be 6 months-ish as a realistic time frame. (May-July) I agree that 4 months may be aggressive, but not for gaining the knowledge of effectiveness.
As for the timing, I attribute our differences in educated guessing to pessimism v optimism. First quarter trial = January 15th to me, to you it means March 31st. I’m just judging by the timeline from others it took others 3-4 months to trial August through Oct/Nov. Two to three more to gain clearance. If regulatory clearances in OUS countries are concurrently happening (which they should be) and combining emergent use cases, it could be 6 months-ish as a realistic time frame. (May-July) I agree that 4 months may be aggressive, but not for gaining the knowledge of effectiveness.
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