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  • scistats scistats Jul 13, 2013 8:33 PM Flag

    The cost of horsepower: Feeding Big Red into a phase 3. Who will "hoof" the bill?

    Reviewing the old Fovea Phase 2b game footage shows the Big Red trial enrollment numbers modified from 600 to over 716 patients. Sports fans, that a lot of patients and 116 more than expected. They saw daylight through the defense and nailed this bad boy across the goal line to put points on the board.

    But the game ain't over.

    Phase 2's are relatively cheap. Skin in the game comes in the phase 3's. The question is: Who wants a dog in this hunt?

    RESEARCH TRIANGLE PARK, N.C., Oct. 12 /PRNewswire/ -- The cost per patient of running Phase 3 clinical studies of new pharmaceuticals exceeds $26,000, on average, according to a new benchmarking report, "Clinical Operations: Accelerating Trials, Allocating Resources and Measuring Performance"

    Lets keep the number at 700 patients. The total off the lot sticker price for a spanking new Big Red phase 3 is $18 million. Now, outsource some of that to India and eastern Europe. Ora can probably streamline it a bit.

    What we end up with is a solid product off the shelf for people who do not respond well to the dozen or so antihistamine drops. In the right hands, the risk reward ratio shakes out quite. Otherwise, Sanofi would have wiped Big Red off a long time ago and Fovea would have never pursued it in the first place. But, it may shake out in the form of cannibalizing aforementioned antihistamines. In this case, Big Red may be unappealing to some. Therefore, we have a bit of a delay. Enter, generic pressure. Big Red is likely to be very affordable so the mark up will not be huge but it beats getting clobbered by generics. Now we wait.

    Odds are good Big Red gets his marching orders in an "if you don't somebody else will' fashion.

    Sentiment: Strong Buy

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