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Maverick0408

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Maverick0408

Re: HappyLibrarian post# 594383

Thursday, 05/18/2023 10:55:56 PM

Thursday, May 18, 2023 10:55:56 PM

Post# of 705460
As I said, they have been intentionally dragging their feet because of the combo trial data. Regulatory applications don’t take over 2 years to complete even if you are team of a handful of (inexperienced) people!

Just think about it:

1) Why did they wait until early 2022 to apply for PIP when the the data was locked in Oct 2020?

2) Why not use CRL or other CDMO as the manufacturing partner in UK? This way, they didn’t have to wait until Advent commercial manufacturing certification to come online. They plan to use CRL in the US anyway.

These steps all seems pre planned to buy themselves time for the combo data to mature and line other steps around that.
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