NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

The July 9 approval PR revisited. It's so solid in detail and information that I (really) enjoy reading it every once and a while.

BOTHELL, Wash., July 9 /PRNewswire-FirstCall/ -- Northwest Biotherapeutics, Inc. , is pleased to announce that it has received Authorization for Use from the Swiss Institute of Public Health (Bundesamt fur Gesundheit; "BAG") to make DCVax(R)-Brain commercially available for treatment of brain cancer patients in Switzerland. As such, DCVax(R)-Brain is the first commercially available therapeutic vaccine for such cancers. The Company intends to begin making the product available to patients in Q3 2007.

Note how they expect to have manufacturing in place in just a few weeks. The concerns this would be some huge effort were clearly FUD.

We look forward to being able to bring DCVax(R)-Brain to patients in additional countries, and to applying our DCVax(R) technology to many other cancers, including the five for which we already have FDA clearance to begin clinical trials."

Clear statement of future trials to be started.

In parallel with making DCVax(R)-Brain commercially available to patients at selected medical centers in Switzerland, NWBT is also conducting a Phase II pivotal trial in 141 patients in the US. The trial began enrolling patients in December 2006, and is anticipated to conclude around the end of 2008. The Company plans to seek product approval in both the US and EU in early 2009, based upon the results of the Phase II pivotal trial.

Super news. TLD from the P2 [the trial that became the P3] in 2008 and BLA/MAA soon after. Assertions it could take many years were clearly lies by shorts.

Clinical trial data to date in brain cancer patients have shown that DCVax(R)-Brain delays disease recurrence by nearly 3-fold, from 6.9 months to 18.1 months for newly diagnosed patients.

This makes the P2 a slam dunk. Being able to measure the 18.1 month PFS clearly proves there is no possible issue with immune reactions confounding the progression.

CONTACT: Linda Powers of Northwest Biotherapeutics, Inc.,

It is good to know that the owner is taking personal responsibility here.

Clinical trial data to date in brain cancer patients have shown that DCVax(R)-Brain delays disease recurrence by nearly 3-fold, from 6.9 months to 18.1 months for newly diagnosed patients. DCVax(R)-Brain also extends these patients' survival from 14.6 months to more than 33 months (and continuing -- median not yet reached).

So no problem measuring PFS in a clinical trial. Makes the pivitol trial a slam dunk.




https://www.biospace.com/article/releases/northwest-biotherapeutics-world-s-first-therapeutic-vaccine-for-brain-cancer-commercially-available-to-patients-in-switzerland-/