Replies to post #63765 on NorthWest Biotherapeutics Inc (NWBO)

[Pyrrhonian]

This essentially leaves us with a rolling review of data up until the scheduled end of the trial unless there is or has been some sort of an ethicist intervention. Linda said they would not apply for AA until the end of the trial. To me this means FDA is actively trying to decipher data which is accruing very slowly while perhaps also working with the other regulator time lines and manufacturing prep so that approval can be expedited if received.

You think there is a rolling review of a BLA going on right now, doc? For realsie?

Two things. If they crossed a stopping boundary for efficacy they would have halted the study and PRed the same. Or, if they needed to keep it going for OS they would have not halted the study and gotten it fully enrolled for OS while putting together and submitting a BLA based on PFS. And neither is happening here.

Not too late to try post # 61820 my friend! Or hey maybe it is. Data could come out tomorrow. Well if it's not you should drop NWBO like a dead fish :)

I remember one of the hardest things I ever reeled in ended up being a snarl of dead sticks. It took forever. The dead weight made it act like a big fish on the line that kept "slipping away" every time I stopped reeling.

[Rkmatters]

Doc Logic,

I agree with you on this. To me it looks almost as if the company initiated the temporary hold, sent in data which FDA then reviewed and asked for continuing data as per Dr. Prins " still accruing patients" comment. This essentially leaves us with a rolling review of data up until the scheduled end of the trial unless there is or has been some sort of an ethicist intervention on behalf of pseudo/mesenchymal patients. If NWBO argues that these patients leave the main trial early and this leads to underrepresentation of this subgroup in the main arm, FDA might listen. Linda said they would not apply for AA until the end of the trial. To me this means FDA is actively trying to decipher data which is accruing very slowly while perhaps also working with the other regulator time lines and manufacturing prep so that approval can be expedited if received. -- Doc Logic

I don't think that NWBO will argue to remove any main arm pseudos, as that would possible disturb the data, as those would end up being the Brad's of the study IMHO. Anyway, it's just too risky to censor patient data.

-NWBO initially paused screening, and then submitted info to regulators, who after reviewing or after some time of dialogue then issued a partial clinical hold, thereby the 8-k that says they had no outright hold in Dec was true, but before March (10-k release) there was an actual partial hold placed, and so we have that language in the last 10-k. -- Pyrr.

He knows I agree with this somewhat, though I think the "issued a partial clinical hold" needs to be changed to "need to allow new screening".