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newman2021

03/11/24 12:52 PM

#677793 RE: FeMike #677790

No. Realistic is May. Recommendation is next week. Your June time frame is that we apply for approval with the FDA in the USA and the RA in Canada. Get it??

JFR161162

03/11/24 12:58 PM

#677798 RE: FeMike #677790

Say the guy who predicted the submission in 2024…no f.. credibility.

meirluc

03/11/24 1:11 PM

#677801 RE: FeMike #677790

For as late as an August approval, the only ray of sunshine that
comes to mind is that by that time, the EDEN automatic manufacturing
method would already have been validated and MAA submissions to
other regulators would not be far off.

My guess as to approval of this first MAA: April-June.
Bullish
Bullish