Sunday, April 26, 2026 8:33:04 PM
Interesting analysis by Peter Davis but I do have some problems with this.
1. LP had told us that the artisan methodology will be employed after approval. The switch to the automatic manufacturing methodology would obviously take many more months and would be material information that should be PRd. So where is that PR?
2. Furthermore, I recall that a few months ago one of our posters wrote that GZ told him/her that he too was frustrated that the MHRA has not yet reached a decision regarding our MAA.
If as a prerequisite to approval, the switch to skip the manual manufacturing method in favor of the automated methodology is correct, it would have been known many months ago and knowing that it would take many more months to certify Flaskworks, GZ would have had no reason to be frustrated with the fact that no MAA decision was yet on the horizon.
Any counter arguments are welcome.
1. LP had told us that the artisan methodology will be employed after approval. The switch to the automatic manufacturing methodology would obviously take many more months and would be material information that should be PRd. So where is that PR?
2. Furthermore, I recall that a few months ago one of our posters wrote that GZ told him/her that he too was frustrated that the MHRA has not yet reached a decision regarding our MAA.
If as a prerequisite to approval, the switch to skip the manual manufacturing method in favor of the automated methodology is correct, it would have been known many months ago and knowing that it would take many more months to certify Flaskworks, GZ would have had no reason to be frustrated with the fact that no MAA decision was yet on the horizon.
Any counter arguments are welcome.
Bullish
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