InvestorsHub Logo

PennyWorld

11/21/21 5:37 PM

#43355 RE: rollup #43354

Rollup... Somewhere I read that Dr JJ stated that the FDA will NOT consider any other 'trial data' for the recently rejected EUA application. Has it been confirmed that the output from the Inhaler trial NCT04360096 (ending 12/31/21) will not be used to reassess the Zyesami EUA application?

rollup

11/21/21 6:44 PM

#43356 RE: rollup #43354

No, the data from the inhaler study (with the end of December 31) are not used for IV.
But the results of the NIH-IV study ended December 31st. 21 / Finished in Q1 / 22 (safety ......) in the decision-making process of the NIH !!! and / or FDA used in Q1 at the latest!

That’s why it’s going to be very exciting in the next few months!