Folks, remember the company is not supposed to tell us anything about what's happening while their MA submission while it's in the hands of the MHRA, but somehow they've managed to tell us everything! Just be giving us a few simple facts!
The first validation date appears to be late, but then there was Christmas and New Year's that may have slowed validation down. But then we get a second commit about "validation confirmed" which appears to coincide with the end of Phase 1 of the application approval process. That might be a little early, but remember, we did hear about the recertification of the Sawston plant and recertification of the live cell storage of Sawston in December 2023, which is likely very important in the MAA process. Then we get this statement:
“The Company did not make any amendment or addition to its MAA after the original December 20, 2023 submission.”
I believe this statement clearly means they were not required to change anything in their MAA. Which would point to the likelihood that they completed Phase I successfully without need for a "time-out" period to make additions to the MAA.
My guess, we will get word from MHRA before the end of May.
All this news without them ever mentioning what MHRA was doing. Just the basic facts.
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