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Re: nerby post# 250098

Wednesday, 11/28/2018 12:35:20 PM

Wednesday, November 28, 2018 12:35:20 PM

Post# of 403070
It's highly unlikely for the posting of study results to clinicaltrials.gov to have any impact on FDA decisions.

It's also unusual to see results posted on clinicaltrials.gov even though all companies are now supposed to report them. Galera hasn't reported their results for their ph2 OM trial and the ph3 is already recruiting. The ph2 doesn't have any results posted, but, that may be due to it still showing as active, not recruiting.

Can a company avoid or delay requirement to post results if they simply don't update the site to completed for years? Would there be competitive reasons to do so early? I find the entire issue curious.





In Reply to 'nerby'
I'm curious if the involvement of the NLM could've had any effect on timing and result of a BTD decision. I don't have a clue.

At least it appears that whatever communications or queries were involved, they were readily responded to by IPIX.

Thanks for the info.



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