The same consultants writing the publication are doing the BLA. They hav an added benefit of more eyes reviewing the data for the publication that can only help solidify the BLA.
I would be shocked with no progress with BLA. It is common sense but it is MWBO after all doing the work.
Exactly, one would hope that the BLA draft is ready and would just need to be tweeked after the pre-BLA meeting. A Type 2 FDA meeting is given within 60 days of the request (I believe). 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. Hopefully I'm not too exuberantly optimistic. Hey, they did say in their latest $15M financing that the money will be used for
The Company plans to use the funding to help accelerate its activities related to its brain cancer program.