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Re: Amatuer17 post# 200766

Friday, 10/20/2017 6:33:17 AM

Friday, October 20, 2017 6:33:17 AM

Post# of 402687
Mongersen, GED 0301, already had unanswered safety questions that appeared in earlier trials. For example, in the Phase 2 trial there were 7 serious adverse events that included a hospitalization and two cases of worsening Crohn's Disease. One reason for moving to Phase 3 was to see if the benefits outweighed safety concerns. The safety committee ruled that the risks outweighed its benefit. The bottom line, Mongersen had serious safety issues before Phase 3 even began. They did not suddenly appear in an expanded trial. http://www.nejm.org/doi/full/10.1056/NEJMoa1407250#t=article

Do you know of any safety issues that we should be aware of with any of the current drugs under review? I mean, other than the safety issues that were remediated through lower dosages or easily treated?

“Celgene's Crohn's disease drug just failed Phase 3 so they might be looking for a replacement in B-UP”

But they maybe more cautious to avoid same mistake of overpaying for drugs with success in P2.

The P3 failure is a cautionary note to all who tout no failures for IPIX - it can come anytime specially when they move to larger trials.


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