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Re: Microcap Article.. this part... To me it is not about what the fda has been asking, it is about what the fda has been denying. There are not fools at the fda. There are scientists and administrators. All levels of involvement. All flesh. Human beings. It is hard for me to forgive them their transgressions against progress. If what PV-10 does to a tumor were subtle, if it were dangerous as a medical agent, if bystander effects were not seen from the outset and consistently to the moment to be precisely what the world has been looking for in a cancer therapy for ever... I do not believe the fda has been objectively doing its job to promote PV-10. In the face of the most challenging disease afflicting millions of people, intransigence. What are called opinions, are my conclusions based on observations. Blaming the company for the five year gap of regulatory progress is an opinion. Yes, my opinion of this is different. I blame the fda. And what my opinion suggests are the reasons and motives for such enduring muddling? Why is it I can see enough evidence to warrant approval from the fda for PV-10, reading their standards for approval, knowing so little comparatively to what they know about PV-10? And they want pain, bleeding and infection data because that is their standard, their box, when the tumor is long dead and bystander tumors are dead and T-cells are confirmed to be prowling the body, specific to the tumor killed clinically by PV-10? Irrational, unacceptable, too long taking arbitrary imposition of regulatory authority. Over here, approval. Over here, hoops. Flaming hoops to the apparent limit of the visible horizon. It is not a Blame Game. It is a dam shame. |
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Msg # | Subject | Author | Recs | Date Posted |
26401 | Re: A Study in Delays | Jraven | 0 | 2/17/2016 3:31:44 PM |
26413 | P3 clinical trial sites | canis_star | 15 | 2/17/2016 4:07:10 PM |