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manibiotech

04/28/25 6:13 PM

#764601 RE: dennisdave #764600

I think poster meant NAS applications not the established medication applications . But I don't what the reality is . May have to listen to the video again . 
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DJPele

04/28/25 6:29 PM

#764611 RE: dennisdave #764600

That appears to be regarding established medicines. Wouldn't our application be a new marketing application, separate from those that are established?
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Steady_T

04/29/25 2:18 AM

#764691 RE: dennisdave #764600

Everyone assumes that the NBWO MAA is backlogged.

If the poster is correct when he pointed out that as soon as ANY RFI is sent to the company the clock stops then it is entirely possible that the MAA is not backlogged.

NW has said that they didn't know that RFIs could come at any time and NW was involved with back and forth answering questions from the MHRA. That suggests that there have been many clock stops rather than 1 or 2.

We have no idea how many days of clock stop there have been. It could be many more than what is usually expected from clock stops 1 & 2.

Edit. I see that this idea was posted earlier. I hadn't caught up with all the posts when I wrote this.