NorthWest Biotherapeutics Inc (NWBO)

[Dan88]

Marzan you are absolutely right that companies should not irk the FDA in any way and form because FDA is vindictive. I guess there is no company which has done a better job than nwbo under Linda Powers, particularly considering the suspected malicious act involving FDA in the partial halt for screening new patients years ago.

Exactly because of that, the relationship between nwbo and FDA has been in the mend ever since, culminating on the lift of the partial halt, which took place years ago later.

Then the suspected involvement of nwbo in the new draft guidance of FDA.

Perhaps FDA has been actually closer than one would suspect in guiding the concluding of our Ph3 DCVax-L trial, sort of as its own experiment/test for the new guidance; perhaps the finalization of its new guidance is pending the conclusion of Ph3 DCVax-L trial.

Anyhow, if FDA's involvement in the Ph3 DCVax-L trial in this stage is true, that would be really interesting.

In addition, I guess maybe FDA has had all the documents necessary for an approval (condition or not) except the final trial results, and of course a formal application.