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News Focus
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XMaster2023

05/28/25 8:14 PM

#769607 RE: barnstormer #769606

The Brits are using the same calendar that many contractors use…,,,
Bullish
Bullish
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skitahoe

05/29/25 12:16 AM

#769626 RE: barnstormer #769606

I believe that when they say 150, they count every day, weekends and holidays included.  In short It's a 5 month period which without any questions to answer, beats the US by a month.  Not saying that is the goal, it's normal to have at least 1 RFI, so 7 months is far more likely for faster approvals. 9 months should allow for 2 RFI's.
I believe that far more is happening here, and the added time may be in consideration of a tumor agnostic label and the EDEN Unit to produce it.  It may not be successful, but if that's what has taken the time, I think it's worth the try.
Gary 
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GoodGuyBill

06/03/25 10:21 PM

#770249 RE: barnstormer #769606

Hmmmmmm...

Did the MAA submitted involve far more than just an approval request for L?

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manibiotech

06/03/25 10:47 PM

#770252 RE: barnstormer #769606

"What am I missing? Did the MAA submitted involve far more than just an approval request for L?"
What you are doing is spreading BS or are pumping . You can read company's PR about what they applied for which is black and white . Now do let us know when was the last time , the company underpromised and over delivered .