Replies to post #484660 on NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

Chiugray, I like most of your timeline components. I do believe you are on the right track. But, I think you need to allow more time for the independent statisticians to develop all of the summary tables and charts for the DCVax-L trial results, after data-lock.

Then, the independent statisticians would need more time to develop the comparative ECAs results (n = 1,366), tables and charts. I believe this step of the process took many months.

[extrooper]

Most everything has been being accomplished over the last 7 months. Sit back and watch as the reveal happens.

[antihama]

Chiugray, for clarity, the FDA must complete its (standard) review process within 10 months of acceptance (not filing) of the BLA. Prior to that decision, the FDA has to decide to review within 2 months of submission of the BLA. So a biotech submits the BLA for review, the FDA has 2 months to decide if it has everything it needs for review of the BLA, and, if it does, has 10 months to complete the review; a 12 month standard process altogether. An accelerated review process would knock the complete timeline to 7 months or less (eg 1 month to accept the review and 6 months to complete review). The 'or less part' is for an 'expediated accelerated review such as for a BTD drug.