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Re: TOB post# 120470

Saturday, 08/29/2015 7:25:53 AM

Saturday, August 29, 2015 7:25:53 AM

Post# of 402724
Why would the results of the Phase 2 Efficacy and Safety Study of Brilacidin to Treat Serious Skin Infections not (yet) be posted to clinicaltrials.gov?

I'm aware from this board that many trial results never get posted, but I'm not clear on why***. Given the conditions of the ABSSSI 2 trial having been completed...apparently with some success, an End-of-Phase 2 meeting with the FDA having been held and the potential value of the QIDP designation, I would hope to see the results formalized on the clinicaltrials.gov on the website. Is that a reasonable expectation? If not, why not?


***I understand that it's not obligatory. In fact the NIH, the sponsor of the website, can't even seem to get it together to require the posting of results of trials that it has provided funding for. Still, is there not some value to reporting positive results in a public venue and not confining it to a press release or a poster for use at a conference? Or perhaps is there a concern that the posting of results of a successful trial would set a precedent that creates the expectation that a given sponsor should be posting the results of all trials, including those that may be less successful? In short, why don't clinicaltrials.gov get no respect?


ps. I guess the same question could be posed of the Purisol Phase 1 test, updated to "Completed" status in March and moving on to Phase 2.

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