Sunday, June 05, 2016 11:11:53 PM
Do you really, really think that the FDA, under the current pressure to quit hindering the approval of safe alternatives in quickly deadly cancers, would be working all these months with the company, asking for documents and scrutinizing the trial, would be doing so if there wasn't something unprecedented going on? Do you really believe that if OS was outrageous across all patients that the FDA wouldn't be breaking their backs to help find a way to be able to approve this?
I have news for you; I'm in this business of medicine and I can tell you that despite all the bullshit that occurs within insurance companies, big pharma, CMS, nurses unions, clinical trials, academia, etc., etc., etc., where everything other than the patient gets prime attention, investigators like Linda Liau and CEO's like Linda Powers will be pushing for that which is real. This thing is golden and looking for a way around the miserable rules that govern the FDA and leave no room for the obvious if the data is being skewed by old assumptions that new findings can prove are not only outdated but unnecessary for approval. This is what's happening, I guarantee it.
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