Friday, November 30, 2018 12:32:53 PM
Possible if trial patients must be Albino pygmies from Africa and the trial size is 25,000. Don't understand at all the expected requirement for a very large trial size as there is no systemic buildup and no safety issues were encountered due to B affecting other parts of the body.
What we have in reality are the following factors:
Numerous people undergoing radiation/chemo in USA constantly. More than enough to fill a trial within a couple of days since there are no other treatments available and there is no major population of possible patients excluded due to safety factors.
Trial only takes 6-8 weeks.
Effectiveness easily determined - Either you get sores or you don't. If you do get them, how severe.
Sachets are providing the exact same drug as was given in P2 as that was a swish and spit version as well. Sachets should be available either now or very, very soon. If a test is determined to be needed, a very fast test on healthy patients could be run to reassess systemic buildup. Sachets put no additional resource encumbrances on existing medical facilities as patients administer themselves at home.
Even if a P3 is determined to be needed by the FDA, they should also allow compassionate use by all that demand it and use those patients as additional data points. I am sure the vast majority of patients to undergo neck/shoulder/head radiation would demand Brilacidin-OM to better their chances many fold in not incurring OM over not taking it.
IMO just more scare tactics to make it look like IPIX is stagnant for a long, long time. To me that is quite a foolish outlook.
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