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staccani

09/25/17 12:17 PM

#1319 RE: gr8db8 #1317

I am not sarcastic and not childish and I suggest you do a better DD before using improper language.
From Q2 conference call, the CEO clearly stated that they are NOT doing an interim efficacy/futility analysis but just a safety review (of course the safety review includes also checking if anybody is dying because of treatment, but that is something different from an interim (efficacy) review )':

'And therefore with this expedite recruitment it happened to be that a time for the interim analysis was actually quite late. And because the one that’s actually in system this interim analysis for the company when we were sitting with the FDA or the SPA, it was very clear that this is almost impossible to be done technically. And therefore, the FDA, of course in our discussion say that there is no point, and they think that we shouldn’t do a formal analysis, just a regular DSMC, because any way we’re getting exactly the same information....'…

Read also the below link (page 16 and 17) and see the difference between an interim safety review (which they are doing now) and an interim effectiveness review (which they are not doing at this time)

https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm127073.pdf