[Goose]

Getting the FDA to answer a direct question in your pre-IND meeting is hard enough...

They'll answer; it's just that it will take 60 days to set up the meeting and the answer you are likely to get is "it will be an issue for review"

BC

Yep. Given these facts, it makes tweeting out anything at all about anything at all hard to justify IMHO.

Right now, the FDA is (attempting to) expanding like mad in the Cell and Gene Therapy area because they are inundated by various filings. The number of "quality" hires they can make is small, partly because they don't pay very well and partly due to the nature of the work. Those "good" hires they make are mostly short-timers who want it on their resume when they apply for a much better job in industry in 18 months. This expansion has also resulted in the usual musical chairs. Just what we don't need in the middle of an epidemic.

[Goose]

Getting the FDA to answer a direct question in your pre-IND meeting is hard enough...

They'll answer; it's just that it will take 60 days to set up the meeting and the answer you are likely to get is "it will be an issue for review"

BC

Yep. Given these facts, it makes tweeting out anything at all about anything at all hard to justify IMHO.

Right now, the FDA is (attempting to) expanding like mad in the Cell and Gene Therapy area because they are inundated by various filings. The number of "quality" hires they can make is small, partly because they don't pay very well and partly due to the nature of the work. Those "good" hires they make are mostly short-timers who want it on their resume when they apply for a much better job in industry in 18 months. This expansion has also resulted in the usual musical chairs. Just what we don't need in the middle of an epidemic.