NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

And.... I'm going to reprint this one more time, because I think maybe it whooshed by people the first time I posted it.

BTW, it's from March 2015. Here it is with some highlights and otherwise no further comment by me.

Accelerated Approval

For the FDA to grant a drug developer access to the accelerated approval pathway, the drug must treat a serious condition and generally provide a meaningful advantage over available therapies. It must also demonstrate an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit or on a clinical endpoint. The effect needs to be measured earlier than irreversible morbidity (IMM) — or mortality that is reasonably likely to predict an effect on IMM or other clinical benefit.

Accelerated approval allows developers to market the drug while it continues conducting a confirmatory study to obtain full approval. This is because approval is based upon an effect on a surrogate endpoint or an intermediate clinical endpoint that is reasonably likely to predict a drug’s clinical benefit.

Real World Example !!!!!

A company was developing a new drug for hormone refractory metastatic prostate cancer. The only available treatment option was with a chemotherapy (docetaxel)-containing treatment regimen. The developer received accelerated approval within 78 DAYS FROM THE DATE OF THE OFFICIAL SUBMISSION. Communication and collaboration with FDA was key to this approval. ALTHOUGH THE COMPANY DID NOT HAVE FAST TRACK DESIGNATION [!!!!], the FDA allowed the sponsor to submit the preclinical and CMC information WHILE THE PHASE 3 STUDY WAS ONGOING. They even reviewed and provided CMC comments prior to the clinical data ever being submitted, thus demonstrating the power of the rolling review.[!!!!]

The NDA was submitted to the FDA in electronic common technical document (eCTD) format. Though not required, the company met with the FDA for a “navigation meeting,” walking through the electronic NDA so that they could better and more efficiently review the application.

During the review, the company received daily requests from the FDA. It was mutually agreed that rapid email responses would suffice, followed by official amendments to the NDA. This agreement also allowed for batching of the amendments, which in turn helped to further accelerate the process. www.pharmexec.com/accelerated-change-understanding-fda-s-expedited-pathways