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Re: loanranger post# 247373

Friday, 11/02/2018 7:51:49 PM

Friday, November 02, 2018 7:51:49 PM

Post# of 403545
It was in reference to this... at the end of the update:

I thought it was relevant in light of the FDA 'refusing to file the application'....

'The setback likely leaves Alkermes back where it was at the beginning of the regulatory process, when the FDA initially refused to file the application and then did an about face and opened the door to a review. The company has another trial underway, but now may well be looking at a requirement to mount new, expensive and lengthy clinical trials that would likely take at least 3 years to complete'


I'm not sure what your "except" refers to. The two situations don't have any basis for comparison.
IPIX has scheduled an end-of-Phase 2 meeting and as long as the materials they've provided are in order it will occur.
Alkermes was seeking an approval, not a meeting.

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