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justdafactss

10/28/20 11:12 AM

#126851 RE: All-Bidness #126849

Mahboob has successfully submitted 16 BLAs

Other than CYDY's PR, where can the above quote be verified?

Whosonfirst

10/28/20 11:13 AM

#126852 RE: All-Bidness #126849

Correct I think resubmitting without the higher dosing will be quickest path forward with US FDA. Can still use higher dosing off label while data Essay data is being worked on. FDA pulled shenanigan asking for more info to delay CYDY while Gilead hangs on for dear life. There is no more wiggle room for FDA to delay. Out time has come out time is near!

Saltz

10/28/20 12:37 PM

#126865 RE: All-Bidness #126849

Not arguing that our new CSO can’t get it done on the original 350ml dosage. Get it done in the US and everything will fall into place. If we had deep pockets we could do it all.

TRYING to do it ALL has not worked at ALL.