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SC8

08/22/23 1:47 PM

#163991 RE: WALLnut #163989

FDA isn't holding up anything. The controlled containment imaging, controlled efficacy studies and the genotoxicity suggestions from FDA would have been anticipated and wrapped up years ago by competent management. Regarding genotoxicity, for all we know issue was raised in comments on first draft IDE application, and when MK finally responded over a year later with a 2nd draft, FDA found the response lacking?

In any event, until RDGL submits an IDE application for human trials, there's nothing for FDA to consider.
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BearGator56

08/22/23 2:55 PM

#163996 RE: WALLnut #163989

FDAs reviewers think its just a game to them to keep adding more testing while the young and old cancer patients succumb to your illnesses.

FDA kinda got it backwards on the fight for life. FDA ok's Isopet to treat and save a pets life, (and its working) while humans continue to die by the millions each year. Thats is a head scratcher.



It's crazy. The FDA has real life evidence with IsoPet but make us jump through hoops further delaying cancer care. What's the need for rabbits when there are animal patients with success stories? Maybe they should bring Moose to DC.

Where's the "cancer moon shot" I keep hearing our POTUS bragging about? What have they done to advance anything? Nothing but hollow statements.