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Wednesday, June 03, 2015 5:57:39 PM
Also, in the trial contract with Harvard medical and Dana Farber there is a clause regarding the control and dissemination of data and reports, as there always is for any contract between a CRO and trial site. Each party-Dana Farber/Harvard, the lead investigator, the sponsor CTIX-all agree to abide by the contract's outline for releasing information. I'm certain Leo must have permission from both Shapiro and Harvard before releasing any and all data. That permission can be very limiting when finally given and especially before the conclusion of a trial with the completion of bottom line data. For whatever reason, Shapiro didn't want Leo to elaborate beyond the information in the poster.
I've been an investor in the biopharma sector for more than 20 years. I have found the limited info during trials as frustrating as anyone. I'm also as disappointed as anyone that Leo didn't elaborate more and beyond the info in the poster, but for me this is not at all unexpected. While it's always great to get as much info from a biopharma as possible, my experience is that the investments to be most wary are those biopharmas who through CROs contract with less reputable clinical sites allowing the release of preliminary data from ongoing trials. Seems these early data releases are always to bolster stock price for rounds of financing and the preliminary data later becomes inaccurate when disappointing bottom line outcomes are finally made public.
Obviously, this won't be the case with CTIX, though there is still the (in my mind very remote) possibility that final data will be disappointing other than primary safety which is already well-established.
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