(Total Views: 345)
Posted On: 06/29/2021 6:59:38 PM
Post# of 36563
I thought pages 5-8 of the last CC transcript spelled things out pretty well. We are clearly nearing the end of the pre-clinical phase.
Still, the info has to get sent in for the FDA's response. The FDA review period and what they might come up for Generex to do could be a problem.
Been through this with CYDY's combo HIV trial and BLA with leronlimab. CYDY gets to to the one yard line and the FDA pushes them back to the 20. And that is after a very promising trial and years of safety and efficacy data.
People need to know that even if a pharma company does exactly what the FDA agrees to with protocol design, the FDA can still ask for more information, sometimes the data wasn't even part of the trial.
Still, the info has to get sent in for the FDA's response. The FDA review period and what they might come up for Generex to do could be a problem.
Been through this with CYDY's combo HIV trial and BLA with leronlimab. CYDY gets to to the one yard line and the FDA pushes them back to the 20. And that is after a very promising trial and years of safety and efficacy data.
People need to know that even if a pharma company does exactly what the FDA agrees to with protocol design, the FDA can still ask for more information, sometimes the data wasn't even part of the trial.
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