Just saw something interesting and relevant while
Post# of 154003
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Posted On: 03/02/2021 12:49:51 PM
Just saw something interesting and relevant while bouncing around the board for KMPH, which I own a little bit of. They have a PDUFA announcement slated for today so at some point it'll be approved or delayed. During late morning trading there was a stop loss raid that halted the market and got everyone hot and bothered about the potential for leaks about bad news. Someone posted a link to their slides from a past announcement to make others feel better and I found this little nugget that I think is relevant to where we sit with the FDA.
(I haven't tried to figure out the picture inlay thing so I'm just going to type out what was on their slide)
KP415 Updates
* Held KP415 NDA late-cycle review meeting with FDA on Dec 1, 2020
* FDA re-affirmed KP415 PDUFA date of Mar 2, 2021, no safety or efficacy issues were raised
* Next step is confidential review/negotiation of draft label
So you see, once a drug is about to gain approval there needs to be some confidential negotiations around labeling. I know that to be true in my heart but it's nice to see a company confirm that it goes down like that. Makes me feel even more confident about what's happening behind the scenes with CYDY.
Yours truly,
Daytime Respert
(I haven't tried to figure out the picture inlay thing so I'm just going to type out what was on their slide)
KP415 Updates
* Held KP415 NDA late-cycle review meeting with FDA on Dec 1, 2020
* FDA re-affirmed KP415 PDUFA date of Mar 2, 2021, no safety or efficacy issues were raised
* Next step is confidential review/negotiation of draft label
So you see, once a drug is about to gain approval there needs to be some confidential negotiations around labeling. I know that to be true in my heart but it's nice to see a company confirm that it goes down like that. Makes me feel even more confident about what's happening behind the scenes with CYDY.
Yours truly,
Daytime Respert
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