Replies to post #139872 on NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

Scott Gottlieb discussed this subject back in a statement made on August 28, 2017.

As we work to protect Americans from the bad actors, I’m equally committed to doing all we can to help bring to patients more quickly innovative, scientifically proven regenerative cell therapies. For this reason, we’re developing a comprehensive and efficient, science-based policy with the aim of accelerating the proper development of these products.

The FDA will advance the new framework this fall. This comprehensive policy will establish clearer lines around when these regenerative medicine products have sufficient complexity to fall under the agency’s current authority, and then define an efficient process for how these products should be evaluated for safety and effectiveness. The policies will be set forth in a series of guidance documents that are the result of a public process we have held in recent years. The new policy will build upon the agency’s current risk-based, flexible regulatory framework. It will also serve to implement provisions of the 21st Century Cures Act related to regenerative medicine. The FDA has already held public meetings to inform its thinking in these areas, so much of the agency’s approach is already part of the public record. We’ll continue to work with industry and the scientific community to perfect the process for bringing safe and effective treatments to patients.

At the same time, we will also issue a compliance policy that, with the exception of outliers potentially harming public health in a significant way right now, will give current product developers a very reasonable period of time to interact with the FDA in order to determine if they need to submit an application for marketing authorization and to come into the agency and work on a path toward approval. And we will also be developing a novel approach to FDA approval that we believe will allow very small product developers to gain all the benefits of FDA approval through a process that is minimally burdensome and less costly. We’re mindful of the significant promise offered by regenerative medicine, the cost of innovation in this industry, the small companies engaging in these enterprises, and the difficulty of doing FDA registration trials in this field. Our framework will take measure of all of these challenges.

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573443.htm

For DCVax-L to be eligible for RMAT designation, they would have to have requested an amendment to their IND. And their guidance indicates this...

We will not grant a RMAT designation if an IND is on hold or is placed on hold during the designation review.
https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm537670.htm

I wonder if the screening halt would have fallen under that description? Well... at least that's over, if it did.

Anyhow... we are well into the Fall now so hopefully within the next month, we'll learn more specific details about their RMAT framework.