Thursday, July 13, 2023 11:05:45 PM
Yup, the million page excuse by LP was indeed a warning sign, but so were also the comments made by LP and LG in summer of 2020 where they lied.
Also waiting for Advent to be commercially certified was another warning sign. They could have used an existing CDMO like CRL in UK rather than wasting 30 months for it to be certified.
I don’t know what is taking them so long. But it’s definitely not due to the contractors. Maybe they have been told their chances of approval would go up significantly if they were to include ph 2 combo data in their application packet? This study is expected to be completed in early 2024. Or perhaps they have been advised to provide compelling data on mechanism of action given the depletion of placebo to fully convince the regulatory authorities. And they are still working on this? Those would be my top 2 guesses. Otherwise, no reason for the application to take this long even if you are a small team of less than a dozen folks.
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