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Posted On: 09/20/2019 11:33:39 AM
Post# of 158203
Quote:
just need to shore up 525 or 700 and a cmc question they believe it will be positive and that they can submit by the end of september.
Read More: https://investorshangout.com/post/view?id=549...z604yNT4gV
I'm just remembered this and I'm looking for this video about the cmc question. This post was July 30th, so probably around then if anyone remembers. I'm curious to see if NP said what the cmc question was about.
One possibility at the end of the FDA's answer to this said question on August 28th, was the FDA said this means you will need to restart the 700mg stability test, but we will accept 3 months instead of 6. A possibility, which seems just as likely, maybe even more, than them forgetting to start 700mg stability.
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