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Re: Justfactsmam post# 316610

Monday, 08/03/2020 3:49:13 PM

Monday, August 03, 2020 3:49:13 PM

Post# of 403487
Most small biotechs can't afford to take this risk.






Message in reply to: Bolded

The problem with EIND single use authorization is that the company has no control or sufficient means to verify and confirm the condition of patient for c"control" purposes. The results of the use must be incorporated into sanctioned FDA IND Humsn trials and if inaccurately reported could skew results of the larger trial ( if many EIN ) or dissuade Trials

Leo has categorically turned down numerous individual INDs for that reason. I sent him one from Two Doctors from India who were working in a major hospital treating patients. They ended up pulling out with hydroxychloroquine and antibiotics



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