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Hspooner

02/23/23 1:44 PM

#570415 RE: flipper44 #570403

Hmmm… Well I guess this shoots the shorts dialogue in the ass, that LP has created Advent for her own private gain. I wonder what narrative they will come up with next?
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dennisdave

02/23/23 1:45 PM

#570416 RE: flipper44 #570403

Anyway, the good news is an MAA submission is not necessary for an MIA license approval, AND, NWBO does not need an MIA license approval as a prerequisite to filing an MAA.



The bad news is LP lying at the ASM and unnecessarily delaying submitting MAA.

Next time Flipper if its not cut and dry communicated by a government organization any other interpretation of any rule or regulation just isnt there.
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MasterKit

02/23/23 2:11 PM

#570428 RE: flipper44 #570403

Maybe the MIA is a prerequisite for RTOR and Orbis. Same paragraph where LP mentions it being a prerequisite, she mentions filing in multiple places...

We plan to file -- we have to get the commercial license first when I was just talking about. That is a prerequisite before being able to submit the application like the PIP, the pediatric investigation plan was a prerequisite. We had to get that done. So we have to have that. But our time line is to file as soon as we can. And we also plan to be strategic about filing in multiple places.
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Reefrad

02/23/23 4:25 PM

#570473 RE: flipper44 #570403

And yet we have not received a PR about an MAA submission. So not sure why it matters that theoretically they could be submitted in parallel.