biopharm, you have got to be kidding.
{{How The FDA Could Change The Way It Approves Drugs
New research from a pair of MIT economists argues that the Food and Drug Administration, which decides which new drugs get to market through randomized clinical trials, is too one-size-fits-all in its approach to the approval process for treatments for everything from leukemia to the flu. }}
So a pair of economists from MIT write an article about how THEY think the FDA should change. Based on that you hang your hat on it as the basis for thinking Sunrise might yet be used for FDA approval. Seriously??? Sunrise is dead.
{{The paradigm shift into Immunotherapy will cause the FDA to adjust with the times, especially when loopholes exist to make a wonder drug look like it just didn't beat out SOC Docetaxel, which it did and it beat out all historic MOS norms.}}
That it not true. PPHM never said the control arm beat out all historic norms. PPHM never gave out the MOS at the time the trial was stopped for futility, that goes for both the control arm of the Bavi arm. Even if the control arm somehow beat all historical norms, it still doesn't help PPHM in the Sunrise trial. You can't just throw out the control arm of a controlled study then expect the FDA to declare your trial a success and approve Bavi. By the way, you do realize that Sunrise didn't even get close to completion.
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