Wednesday, August 21, 2024 3:43:46 PM
Assuming that NNVC's CRO/associates did not fudge the data - given an possibility I would not entirely put beyond Diwan or somebody he would hire - there was no toxicity shown in any of the dosing types that were tested in the Phase I trial in India. I met the guy about 9 years ago and he seems smart - but he's slippery in getting a straight answer from.
The fact remains - yes - the FDA hasn't agreed with the results and signed off on them as of yet. The FDA hasn't seen any of the finalized results yet. A technicality at this point, but a significant technicality. And I will agree with you on this point.
So NNVC making official claims that there was no toxicity observed at the tested levels of their drug candidate in public statements is - indeed - something that they should be careful about stating until after FDA review and approval. The FDA emphasized that point in the letter than you cite.
That also doesn't change the fact that - again unless the Indian doctors have lied or Diwan is lying (again a possibility I don't completely rule out) - the drugs have shown no toxicity at the dosing levels that NNVC is recommending. And since the drug candidate has shown no apparent toxicity in their animal model studies to date, there is little reason to think that it's going to start showing significant toxicity in humans vs other mammals.
I DO my due diligence. Perhaps you should be more honest about your motivations here. Harping on, and on, and on, and on, and on,... About the same flippin' nonsense daily gets old dude.
This all is why I want Diwan to pull his head out of his behind and get that data finalized so that the company can get it in front of the FDA and so that the FDA can do its thing.
“The two most powerful warriors are patience and time.”
- Leo Nikolaevich Tolstoy
Recent NNVC News
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