...and I got closed down so often on Hot Copper for daring to suggest the delayed Mt Sinai/NIH recruiting was an issue. Literally MSB has been hamstrung by playing by the rules again. They were on the CTSN network for trials. Everything by the book, whilst vaccine trialing goes on ad-hoc by companies. They couldn't get 300 patients trialled in six months by the NIH in a country that has 28,000 critical cases on the go! Sorry that is a joke and it should have been a big red flag to us all, but like most I genuinely believed they'd make at least 50% mortality improvements, particularly given SI's persistant 60%+ control cohort mortality calls.
If he knows the effecgiveness with time in the study, he has to know primary endpoint stat at each analysis surely?
I've found FG obtuse and rude in the GvHD call. Contrite in the CHF call. How was he today? Sorry but as a US CMO questions have to be asked. At best poor collaboration with the FDA in GvHD. Poor trial design in CHF. Absurdly slow recuritment in a dynamically changing pandemic.
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