NorthWest Biotherapeutics Inc (NWBO)

[maverick_1]

FINALLY a Voice of Reason (Doc_Logic) thru the perpetuating FOG:This is very likely where it's at!

This IMHO makes the most sense and coincides with my own and very likely Flipper's view last night,

The more this board transitions to the below the more productive for this board IMHO.

This reasoning is one of the reasons I suggested a while back that a BLA for the Phase 3 had probably not been applied for. Linda's MO is to take everything one slow step at a time. What makes more sense to me is that the pseudo trial has been reviewed and a petition to include results into the main arm has been asked for but with eventing being so slow and late rapid enrollment, a determination of effectiveness has not yet been determined. Along with this the test for determining patients most likely to respond, utilized by UCLA, may also be in the process of review with DCVax-L patients to date. Couple this with the manufacturing equivalency issues in preparation for commercial launch, the extensive and time consuming effort required to produce a BLA (MY COMMENT:THE NWBO STAFF? HAS BEEN OVERTAXED~12 people dealing with 3 Regulatory Agencies(consigned in Europe to experts: A post of mine over two yrs ago) and two Key trials: Why many WELL FINANCED emerging biotechs HAVE a highly skilled and EXPERIENCED FDA REGULATORY AFFAIRS EXECUTIVE to file a BLA which is voluminous: ie. can amount to 10K pages vs the IDIOTIC posts of those in the past for a CFO!when NO product for sale) and Linda's promise not to apply for AA until the end of the trial and you have the makings of a methodical push forward with the march of time not on the side of favorable financing unless Linda does something unexpected.(MY COMMENT:ANGEL INVESTOR: ie Dennis Mehiel to double down; CI Ptnr etc) Ethically speaking, regulators will need to make some sort of determination on the pseudo progressors to allow them to get access to treatment if data is overwhelming enough. This decision may hinge on commercial quantity availability both in the US and Europe which is why I have said to keep an eye on manufacturing readiness[/b(MY COMMENT: THATS WHAT I"VE BEEN DOING and reposting to Flipper). We can only hope that at least some patients (pseudos) will have the chance to benefit from this treatment soon. Best wishes.