Replies to post #432206 on NorthWest Biotherapeutics Inc (NWBO)

[FeMike]

Say we get TLD by the end of January. NWBO requests a meeting early Feb, they have the meeting by early April, and if things look peachy, submit the BLA by the end of May. Around ASCO, tell the world they got Breakthrough Therapy Designation/Fast Track status, and get approval 7 months later i.e. December.

Does not compute.

Have you seen the grocery bag?

Approval guaranteed by April. Any other timeframe is nonsensical.

[antihama]

tell the world they got Breakthrough Therapy Designation/Fast Track status

Oops, meant to say Priority Review not Fast Track and Priority Review would be 8 months not 7 (2 months to accept BLA and 6 months for PDUFA date or 4 months shorter than normal review) unless they get Breakthrough Therapy Designation where they can get a version of Priority Review called Expediated Review which is one month shorter (depending on Agency resources) which would get a BLA in the December timeframe I mentioned. Most of the benefits of BTD have sailed but they would still get the benefit of a rolling review, more communication, and also skip the ADCOM meeting. I base the Dec BLA on getting TLD/publication this month and NWBO having internally worked on the BLA over these last 14 months since DL. Any delay to the January TLD timeline would delay the BLA timeline accordingly.

To all those who say the BLA is w the Regulatory Authorities I sincerely hope you're right and I'm wrong. Nuff said.

[Maverick0408]

I’d expect that they would have had pre-BLA meetings already and if things go well, the BLA is submitted this quarter as well. That Lancet article came out in early October. I’d think the company must have reached out to FDA to schedule a Type 2 meeting soon after that.