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Re: JTORENCE post# 690925

Sunday, 05/12/2024 11:18:41 PM

Sunday, May 12, 2024 11:18:41 PM

Post# of 694218
Approval as late as the Spring of 2025 is completely unrealistic.

1. The 150 fast track started with the MAA submission on 12/20/23 and
Spring 2025 would consume at least an additional 10 months.
Even before 2024, MHRA decisions were not rendered more than
a year from submission.
2. I am guessing that of the 86 trial sites perhaps 10-20 (a representative sample))
were inspected so as to make sure that the trial records represented the
required procedures. I am quite certain that most of those sites have
already been inspected and that the remaining inspections will be
conducted within the next few weeks because I very much doubt that in
the absence of approval by sometime in early June, the ASM would
have been scheduled for no later than late June.
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