Thorpe and Company did address it, but not enough to appease the FDA being a bunch of nit-pickers that they are, especially now that Vioxx, Avastin, Celebrex, Aleve etc are in the spotlight for causing cardiac distress. I think Team PPHM had to conduct testing for a few more animal models to prove to the GODS the dose they want to test in humans will not and should not induce thromboGENIC events. If the company indeed had to do this and the FDA says run with it then fine so be it, they have more than enough data on hand now and there should be no further reasons for delaying this Phase I study.
I personally would like to administer the new animal data to the FDA.
Nurse in training,
katie...
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