when it is two 350mg shots or have we never done a
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Posted On: 09/27/2019 9:32:56 PM
Quote:
when it is two 350mg shots or have we never done a stability test on any of the doses?
Outstanding observation! I can't believe no one thought about his sooner. Why does the FDA need stability on 700mg when it is just two 350mg shots? My guess when NP said they needed the FDA to answer a question for part 3, maybe this was it. With that, to me it makes sense they would think the stability data would be done. WTH FDA, WTH....
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