Replies to post #63041 on NorthWest Biotherapeutics Inc (NWBO)

[md1225]

Wow thank you!!!

[eagle8]

Thanks for the great work RK.

GLTU

[Reefrad]

It's an interesting theory. Although I don't completely buy it.

Why would the company not disclose this? Knowing this does not jeopardize the trial.

I doubt the company would choose to delay this trial by so long just to enroll a few patients in Germany under this new patent.

[highwayman4life]

Thank you RK, great find!

[Doktornolittle]

"The excellent news is the process is now complete, and within a couple of days we should hear news that all is fine, assuming that is what the screening halt was about. All claims have been satisfied and updated as of Wednesday, May 25, 2016."

That would be wonderful RK. Even if it doesn't happen sounds like you have really been on top of this.

Hope I didn't miss any key points: But I wonder if they decided they want the remainder of the patients to come from Germany due to allowed TMZ regiment changes, and wanted this new mfg method for the DC's... so that any confirmatory would have a group with the mfg process they want to use immediately after approval or early approval or AA or whatever... but as you say, Germany was waiting for this patent to allow the use of this mfg method.

This is putting together some of Flippers input with your input. In this case the regulators would have given the nod to the mfg method provided there is a confirmatory group, albeit small, but they did not yet give the nod to the change in the TMZ regiment... or perhaps a nod only in Germany. Thus this last group would serve as both confirmatory for the mfg method approval and as more data for later arguments about the TMZ regiment for all countries/regulators.

If so, the when lifted, screening, if any, will happen only in Germany. Though Flipper spoke only about the HE patients as having the option to tweak SOC, in this case probably TMZ. Are those HE patients part of the main trial group in spite of having the option to tweak SOC?

[sentiment_stocks]

Excellent research RK... I remember your dialogue with Lady Grey concerning the number of doses manufactured for her friend.

This verbiage you cited...

www.nasdaq.com/markets/spos/filing.ashx?filingid=9193123

Recent Developments

On September 10, 2013, we announced that we had been issued another U.S. patent (#8,518,636) covering a next-generation process for manufacturing lower cost human dendritic cells of both a higher quality and higher reliability. This next generation system has already been cleared by the FDA for use in the manufacturing of dendritic cells for our clinical trials. These systems are now in use producing the vaccines which have already been injected into the tumors of DCVax-Direct patients.

(combined with)
Changes in manufacturing methods for DCVax-L could require us to conduct equivalency studies and/or additional clinical trials.

(along with)
With biologics products, “the process is the product”: i.e., the manufacturing process is considered to be as integral to the product as is the composition of the product itself. If any changes are made in the manufacturing process, and such changes are considered material by the regulatory authorities, the company sponsor may be required to conduct equivalency studies to show that the product is equivalent under the changed manufacturing processes as under the original manufacturing processes, and/or the company sponsor may be required to conduct additional clinical trials. Our manufacturing processes have undergone some changes during the early clinical trials. Accordingly, we may be required to conduct equivalency studies, and/or additional clinical trials, before we can obtain product approval, unless the regulatory authorities are satisfied that the changes in processes do not affect the quality, efficacy or safety of the product.

... all argue strongly that they intended to make the switch to the TTF method back in 2013. And the subsequent recent upgrades at Cognate and Fraunhofer, as well as the upgrades taking place at Sawston all support this premise as well.

As for Germany holding off on approving that patent until a few days ago... that really is an interesting development in the whole scenario.

[Steppenwolf_Speaks]

So what you're saying is...

NWBO destroyed 92% of shareholder value for this. You're also saying NWBO couldn't even hint at all this...most of what you think you uncovered could be shares with shareholders.

Sorry, but it all this was spot on, then they wouldn't have let this go to $0.72 because of it.

[joeycav11]

Amazing due diligence! Thank you RK