Replies to post #758734 on NorthWest Biotherapeutics Inc (NWBO)

[ilovetech]

The application size and its extensive interagation should leave nothing to the imagination for other regulators to want more than what's been provided. IMHO.

[DrHigh]

and now they are poised to submit regulatory applications to the FDA and Health Canada, in the upcoming months

you are an incredible gaslighter. They just began to engage consultants to prepare for other applications and you are saying they will be ready in months

[antihama]

I see it in a different light. Back engineering what transpired, one, or at least I, come to a different conclusion. Advent had to be built up; Cognate was several years ahead of them. They had solidly established manufacturing here in the US w Cognate, and the US is the most desirable market to launch so why pivot to Advent/MHRA when you had the marbles lined up for the US? There was no LP greed involved as some assert, it was strictly because the FDA may have thrown up some roadblocks, and LP sensing receptiveness from the MHRA via Dr Ashkan, saw it as the easier road to navigate. And yes, I see the EMA application next in line, hopefully before the end of the year. Sawston serving the EU makes lots of sense.

Regarding, the FDA mandated control arm, I don’t think anybody (FDA/clinicians) foresaw the PSPD created by the DCVax-L arm, throwing a monkey wrench in the data w the FDA then having an issue w the non-patient level ECA. After MHRA approval, and as RWD/RWE accumulates w the specials program, I think that will ameliorate a pathway to FDA approval. That’s my take and whatever you said in your previous post or say in a future post will not change that.

[exwannabe]

I don’t believe the External Control Arm (ECA) is a problem with the FDA either. The FDA were the ones who mandated the crossover option for all of the patients in the DCVax-L Phase III clinical trial.

A total lie (the second sentence, first clause is your opinion of course).

From the SAP in the JAMA paper (if you believe it):

Such a large percentage of patients made use of the crossover option in the Protocol that the original control arm became substantially depleted and insufficient for OS analyses within the Trial. When the Trial began in 2007, per the demand of investigators and patients it was necessary to include a crossover option in the Protocol in order to recruit and retain patients.

Further, when designed it was a P2 not designed to establish OS. And the primary endpoint was not affected.

And as far as this statement by you:

According to the recent 10-K, NWBio has been talking with about 6 CDMOs, strategically located throughout the US, and now they are poised to submit regulatory applications to the FDA and Health Canada, in the upcoming months.

As they are presently looking fior a CDMO they are not even close to submitting. This is very basic, the CDMO needs plenty of time to be ready, and that is not months.