Manufacturing requirements are killing cell and gene therapy

Yesterday, ultra-rare disease company Grace Therapeutics announced it may be forced to shut down after the FDA requested a second manufacturing run before it can submit its new application for approval. This is a requirement the company says it simply cannot survive, as it would require another twenty million or so in funding. I explained in a tweet why the requirements the FDA has regarding this are absurd.What I really want to bring home though is that the story of Grace Therapeutics is not un...