NorthWest Biotherapeutics Inc (NWBO)

[marzan]

Yes FDA has released this guidance document that supports approval based on SOCs when placebos were allowed to crossover like in our case. There are several flexibility offered in this guidance document help our therapy land an easy approval. On top of anything, our Data speaks for itself. Recall LP is saying 13 years of history making Data. Wherein any cancer trial this hank guy find 20% patients living for 5+ yrs. Forget about GBM, ask him to show me any lesser severity solid cancer. There are fudsters today I tell you. No sledgehammer can slow this express train. The speed picks up any hour now.


https://www.fda.gov/regulatory-information/search-fda-guidance-documents/demonstrating-substantial-evidence-effectiveness-human-drug-and-biological-products