(Total Views: 695)
Posted On: 11/10/2020 10:06:56 AM
Post# of 148899
I share your frustration but it's also worth noting once again that NP never officially asked the FDA for EUA for m/m in August. He just chatted with them on the phone. While he has since defended this approach as being superior since it avoided a potential "black mark" of rejection by the FDA, we'll never really know what would have happened if the FDA was forced to go on record and review our data and respond with an explanation of how they reached their decision. Here's an example of an FDA EUA rejection letter:
https://aapsonline.org/FDA-EUA-HF-rejection-letter.pdf
Forgive me for possibly beating a dead horse but in light of this other EUA news, I don't believe NP's decisioning on this is beyond reproach.
I think the following two phrases might apply here:
"Ask and you shall receive."
"If you don't ask, you don't get."
https://aapsonline.org/FDA-EUA-HF-rejection-letter.pdf
Forgive me for possibly beating a dead horse but in light of this other EUA news, I don't believe NP's decisioning on this is beyond reproach.
I think the following two phrases might apply here:
"Ask and you shall receive."
"If you don't ask, you don't get."
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