Hygro is the most dedicated Fudster, and paid while at it that Ive ever seen. It’s that or he is employed by BP or a huge stockholder of BP with the most to lose when NWBO IS ever granted approval. However, BP could also be a huge winner with NWBO being successful.
The FDA believes and the guidance states that contemporaneous external controls are appropriate if the natural history of a disease is well known which is certainly the case with glioblastoma. This recent FDA guidance provides more clarity.
“Drugs based on contemporaneous external controls is not new for the FDA. It is almost always the case that drugs targeted at orphan diseases use contemporaneous external controls so that many, many drugs have been approved that used contemporaneous external controls. Note that GBM is an orphan disease.”
Bottom line DCVAX-L has already shown the dramatic increase in survival. If I or my loved one was to diagnosed with GBM then I hope and Pray that DCVAX is an approved treatment. And I hope that’s the biggest reason the regulators should approve. I can’t imagine striking out their best hope and treatment on the planet today!
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