Replies to post #300438 on NorthWest Biotherapeutics Inc (NWBO)

[Idunno]

Thanks to you both for the interesting dialogue. The beauty of message boards.

[biosectinvestor]

Agreed. The opportunity to likely get the whole platform approved more quickly, with many fewer trials seems not just in the company’s agenda, but I think the FDA is working toward that regulatory framework and has been for a while now.

The short case is just sandbagging and trying to pour on anything and say anything that might discourage potential investors or current investors.

Just my opinion.

[Evaluate]

I hope you are right!

It seemed to me that the company had a SAP that simply needed finalizing in the fall of 2018, but may have gotten wind of (or had something to do with) the new FDA Guidance that came out last year and then apparently decided to completely rewrite the SAP.
I suspect that Dr. Duffy was heavily involved in that process.
So the Direct trials were put on hold to redesign and update the protocols and endpoints, and while this appears to be a backstep, it may actually end up being many steps forward in the long run.

That is why I find this tidbit in the 10Q somewhat encouraging in regards to Direct: that the trial design activities and preparations with the trial sites continue.