Doc,
To the best of my knowledge the date of the Journal won't matter to the regulators, what matters is the date of the BLA submission. Typically the PDUFA date is 6 months after the BLA is filed, but of course the regulators are free to act prior to that date. More often than not however they're likely to put off the PDUFA date rather than acting early, Covid-19 no doubt is one reason things are taking them longer. I don't know if people in Dr. Padzur's staff are being pulled in to assisting others who're working on Covid-19 based therapeutics rather than the oncological products they are the experts on. Of course some key people may also have gotten it themselves.
Frankly I just heard that a friend, who was fully vaccinated and boosted, is suffering with a pretty serious case of Covid-19. I don't know if Omicron has been confirmed, but she's elderly and her medical plan doesn't appear to be rushing to get her the MAB's that might prevent her needing to go to the hospital. Up to now I've taken precautions, but tried to still see friends and get together for lunch weekly, I hate to do it, but I'm listening to my wife and family and agreeing not to do so until we come down from the peak which still hasn't appeared to yet be reached here in L.A. Hopefully Omicron will back off in a month or two, but until it does I'll be more of a hermit.
Gary
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