I am not a bio pharmacist, but I have a lot of experience in large technical national security contracting. The contracting process is complicated and very much data and government form driven. In that way I see parallels to the BLA process. The more contracting decisions where I was involved, the more similarities I saw! There were instances when a company would submit a proposal and would seem to have the wherewithal to create a strong submission but missed the mark. Even after a preliminary review conference when contractors could hear the priorities and ask questions, their amended submissions would still miss the mark. In the BLA process, it seems that the FDA took the time to point out deficiencies. But now we hear that the amended submission still missed the mark with the data provided. I believe that NP needs to look at the team that is responsible for putting together the submission and strengthen it with new people, successfully experienced people and an outside review board. I don’t know what will be the steps for COVID approval but I worry that if approval is dependent on the current BLA group, delays could be the future. I hope Dr BP plays an instrumental role in any COVID submission, as I find his presentations strong and clear.
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