“It really upsets me that the FDA does not reali

“It really upsets me that the FDA does not realize what a company has to do to get through a trial and get approved even when the drug shows nothing but perfection.”

Thanks for your perspective on the warrant exercise offer underway. I recall Nader once saying “we may have seen our last raise” and “this will be the year of approvals.” Equal disdain and criticism should be extended to Amarex as we are now feeling the real financial burden they placed on Cytodyn. $100 million doesn’t begin to cover the damage. Had they done their job and found FDA approved the drug we would be in a very different circumstance.

We will get there, this too shall pass. I choose to look forward to a CRC trial commencing and hope it is powered for and they factor in a DSMB peek half-way…one can also hope for a study halt for efficacy, which make us forget this long journey much as a woman forgets the pangs of childbirth in that moment of joy. Maybe this is truly the end of the beginning.