Replies to post #743579 on NorthWest Biotherapeutics Inc (NWBO)

[HappyLibrarian]

That being said, I don’t know how things work behind the curtain. Maybe if MHRA want to reject, rather than going through a CHM review, they can simply relay to the sponsor that they would recommend withdrawing/resubmitting. Who knows.

If so, any reasonable person who is a shareholder would regard such a recommendation as material to their decision to remain invested, sell or buy more shares

[tunnelvisionofplenty]

Indeed, who knows. Maybe medicines that the MHRA is not inclined to approve are simply not recorded in the minutes in the same manner as other medicines; that is, they do not "consider and advise on" them in the same manner. For me, the main point is that DCVax-L appears in the minutes in the same manner as a group of other medicines of which 90% have been confirmed approved.

[biosectinvestor]

My understanding, and of course none of us can see behind the curtain here...

The MHRA is a collaborative regulator rather than one that seeks to be unnecessarily punitive. That is pretty much the style for the best regulators. So I agree with you on that point.

If an application has merit and the MHRA sees potential for approval, it would be reasonable to expect communication with an applicant and that might lead to some further clarifications and resubmission. They do not lean toward an outright rejection. That kind of advice can be seen as a positive signal, as it suggests the regulator is willing to work with the sponsor to achieve an approval. Of course, none of us know what is going on, and this is purely speculative, but my view is generally the regulators see themselves, to a large degree, as collaborating with researchers to get good treatments to patients and to the market, not to punish anyone with outright rejection, if a company has a fundamentally good application that the regulator believes will, if approved ultimately, benefit patients. Basically, it's a back and forth for treatments with promise.