I agree that the BLA submission is key and am a li
Post# of 155002
(Total Views: 388)
Posted On: 01/19/2020 1:47:50 PM
Re: Cytodynamite #15443
I agree that the BLA submission is key and am a little frustrated that NP is going to give day by day updates on cancer patients but only vague updates on when BLA will get submitted “ by the end of January - hopefully.” It was previously sept, then dec now End if Jan.
I feel that the CMC section with the delivered stability data should be in by now. This is our technical leads primary job and assuming for each billion in peak sales a one day slip costs between $3 and $5 million in sales (depending on whether you use business or calendar days). To take advantage of rolling review, individual sections need to be put in quickly to give a chance for comment. As evidenced by other recent non approvals the Mfg section is an area of FDA focus and concern.
It would be nice to know the specific status - all sections updated with stability data -final reviews underway and pending a clean review should be submitted this coming week.
The key to everything is to get this drug approved - without that, there is no such thing as label extensions.
IMO only
I feel that the CMC section with the delivered stability data should be in by now. This is our technical leads primary job and assuming for each billion in peak sales a one day slip costs between $3 and $5 million in sales (depending on whether you use business or calendar days). To take advantage of rolling review, individual sections need to be put in quickly to give a chance for comment. As evidenced by other recent non approvals the Mfg section is an area of FDA focus and concern.
It would be nice to know the specific status - all sections updated with stability data -final reviews underway and pending a clean review should be submitted this coming week.
The key to everything is to get this drug approved - without that, there is no such thing as label extensions.
IMO only
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