Replies to post #260429 on NorthWest Biotherapeutics Inc (NWBO)

[vator]

“He mentioned there's a new policy down at the FDA they're waiting to have SOC from other trials to be used against our treatment patients to help the statistical significance. And that they're waiting for the FDA to implement that new policy. And this new policy might be useful to NWBO.”

The board has been arguing over this endlessly. This would put it to bed.

[Pablosrv]

This is discouraging. Still with the SAP....gosh. And they have to wait for new FDA policy on PFS cause we have failed this endpoint. Very NWBO, as usual.

[BioInfo]

"He mentioned there's a new policy down at the FDA they're waiting to have SOC from other trials to be used against our treatment patients to help the statistical significance. And that they're waiting for the FDA to implement that new policy. And this new policy might be useful to NWBO."

this is huge and I have been saying all along, SOC data should pretty much be the same as other trials. We do not have clean SOC data due to crossover, I think its logical and would be beneficial to adopt SOC data from other trials, and rest is all improvement DCVax did. difference is DCVax!!!

[learningcurve2020]

Thank you! Never ending. I was expecting this...The control SOC figures changed and I doubt will help NWBO.

Trust your gut. IMO Powers has dragged this trial out years waiting for the chemo $$ complex and FDA to loosen up.


>>He mentioned there's a new policy down at the FDA they're waiting to have SOC from other trials to be used against our treatment patients to help the statistical significance. And that they're waiting for the FDA to implement that new policy. And this new policy might be useful to NWBO

[TiltMyBrain]

I have my doubts to whether this conversation actually took place.

[HappyLibrarian]

We can cling to the hope that like many phone conversations with Les Goldman or David Innes reported here, it is not true or that what he was saying was misinterpreted.

But if true, what you are saying offers a bleak outlook because NWBO will remain at the edge of bankruptcy in a holding pattern with no end in sight and with the best outcome being more punishing dilution and the need to do ever more averaging down just to have a hope of seeing a profit after more years of waiting.

NWBO needs to hold an ASM promptly or do a letter to shareholders and come clean on the timeline for the trial instead of leaving it to third parties, however well intentioned to drop a bombshell like this.

While I would love for what you said to be wrong, it is becoming clear that the end of this misery for longtime shareholders is nowhere near imminent or soon or any other feel good term that gets conjured up.

[sentiment_stocks]

BWIS, this recent FDA guidance (that FDA is waiting on input for) may very well prove extremely helpful and is also quite timely. I believe the opportunity to provide commentary is up in February. In the meantime, it doesn’t really make any sense for the company to “wait” to unblind this trial for this guidance to be implemented. I state this because after unblinding and after top line, the company still has to assemble their BLA (as ex is so fond of reminding us). And by the time that guidance is in effect, the BLA with the FDA may not yet even be filed. And if the BLA is filed before the guidance is formerly implemented, as ex is also fond of reminding us, the guidance is already at this time pretty much in effect.

My guess is that LG was simply taking the opportunity to remind you of the recent guidance, and how relevant and timely it is, and how it confirms a lot of things LG has been telling shareholders the FDA seems prepared to accept these past few years. However, I doubt very much that he meant to imply that everything (or anything for that matter) about the L trial was on hold until the guidance was finalized.

[drugrunner]

BWIS-- WHO LIMITS YOU TO ONE POST A DAY..

I get 15

[jammyjames]

"The problem I have with this is:
If mgmt believes we need a change in FDA policy to improve the likeliness of success. Nwbo is something less confident without that change despite their ravings about not seeing life longevity in a trial like this before. These 2 things seem to be at odds with each other. I've felt for a long time that they are afraid to complete and submit the trial while others here seem to argue."

Not necessarily at odds when youfactor in the cross over and that 90% of patients received DCVax-L

"He mentioned there's a new policy down at the FDA they're waiting to have SOC from other trials to be used against our treatment patients to help the statistical significance. And that they're waiting for the FDA to implement that new policy. And this new policy might be useful to NWBO."

It will interesting to hear what this is. I've always thought it would be useful to have a standard database complied by the regulatory bodies for different cancers which anonymously lists the outcome of patients on SOC. That database contains explicit information about the more common variables that go into inclusion/exclusion criteria (i.e age,sex,KPS score, extent of resection etc.). That database can be sampled from by companies running onco-trials using the same inclusion/exclusion criteria as their own and used as part of the evidence for drug efficacy. Would for sure help with stat problems arising from cross over and the ethical issues of recruiting patients into a placebo arm. Note that this would be no substitute for a concurrent control arm but could be used as extra supportive evidence which would for sure help companies like NWBO out.