Replies to post #659578 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

Understood. I know exactly what it is and was. However it was an early access designation as was the HE, which you conspicuously failed to mention, and both, after review by the regulator and in the context of the HE included substantial due diligence, decided to include a BROAD designation when it wad not even applied for…

https://nwbio.com/nw-bio-announces-two-german-approvals-hospital-exemption-for-early-access-program-with-dcvax-l-and-eligibility-of-dcvax-l-for-reimbursement/#:~:text=Under%20this%20Hospital%20Exemption%2C%20NW,be%20from%20Germany%20or%20elsewhere.

The approval of the Hospital Exemption for DCVax-L is the culmination of nearly two years of regulatory processes and scrutiny, starting with a Scientific Advice process during 2012, and followed by an application for Hospital Exemption in December, 2012. The evaluation of NW Bio’s application by the German regulatory authorities included comprehensive and detailed scrutiny of all aspects of the DCVax-L technology, all DCVax-L clinical data to date, all manufacturing processes, all product characteristics (including potency, composition, sterility and other aspects), all frozen storage of DCVax-L and frozen shelf life, and all distribution and handling of the DCVax-L products.

Although Section 4b of the German Drug law for Hospital Exemptions was implemented in July 2011, the approval for DCVax-L is the first such approval granted by the German regulatory authorities in multiple key ways. Only two prior approvals have been given in the more than 2-1/2 years since the law was put in place, and those were for two German companies with tissue engineered products which had already been on the market commercially under prior laws and were grandfathered for regulatory purposes, and which did not have pharmacological (i.e., drug-like) effects in the patient’s body.

In contrast, DCVax-L is the first product of its kind to receive Hospital Exemption approval from the German regulators, in the following key ways:

the first immunotherapy;
the first product which exerts pharmacological (i.e., drug-like) effects in the patient’s body;
the first product that has never previously been on the market commercially;
the first product developed by a non-German company, not previously under the German regulators’ oversight; and
the first “somatic” cell therapy product (a somatic cell is any cell of the body other than a reproductive or embryonic cell).
Furthermore, the scope of the Hospital Exemption granted for DCVax-L is broader than the scope of NW Bio’s ongoing Phase III clinical trial (which must focus on a homogeneous set of patients in order to produce data that can be compared between treated and control patients). The Hospital Exemption for DCVax-L applies to all glioma brain cancers, including both the most severe grade (Grade IV, Glioblastoma multiforme or GBM) and lower grade gliomas, while the clinical trial includes only GBM. The Hospital Exemption also includes both newly diagnosed and recurrent gliomas, while the clinical trial includes only newly diagnosed.

Based upon data from the German Brain Tumor Association, there are approximately 7,000 new cases of gliomas (primary brain cancers) per year in Germany. These would include approximately 3,000 cases of Glioblastoma multiforme (GBM), the most severe grade of glioma (Grade IV).

DCVax-L products that are to be covered by the Hospital Exemption in Germany must be manufactured in Germany, but can be administered to patients from anywhere. …

Of course manufacturing in Germany is a bit if inserted protectionism requiring they set-up a factory in Germany, which was a non-starter. Nonetheless, the due diligence and desire of the regulator was clear.

[biosectinvestor]

They did not apply for EAMs because it was a crap program just like the U.S. current early access program. It put the burden on the companies to supply the drug at their actual minimal cost, which would not recoup scaling up a factory, hiring people, getting a commercial license and basically operating as if they were a commercial entity. That was a non-starter not just for NWBO, but if you peruse the companies that went through the hurdle of the initial designations, you’ll see that it required regular renewal and most did not bother. The EAMS program basically was a failure, hence the U.K. Specials program as a regulator driven work around basically.