Folks: In the interest of posting contrarian view points that have content (unlike those of sych and jneslon), exwannabe posted on the iHub Biotech Values board this:
“From 20,000 feet you still have a drug that failed the primary endpoint of DFS in a single trial going to the FDA on survival. But the details are significantly worse than in the better known example of DNDN's Provenge.
In the AC meeting last year when the drug (then Junoven) was voted down the FDA presented briefing material that was very negative.
. Numerous trial flaws (no defined endpoints, unplanned interims, serious dataset questions). And a big one was that randomisation for MTP was done well before the drug was used (which adds noise).
. The assumed primary of DFS only hit stat sig if results from another experimental drug were included. W/o infosfamide there was little effect. [Read the transcript for the place where the lead investigator tries to tap-dance around the SOC issue, very funny]
. Much of the OS power in the results derived from events before MTP was administered. W/o events from that period, the P value was around .5
Yes, they have recent follow-up data which pushes the OS P value to .03, but that doesn't fix the other issue.
Approval, nope.
BTW, the phrase "possible clinical benefit" sounds to most like ‘the P2 worked, on to P3’ ”.
COMMENT:
It appears to me that exwannabe is not taking into consideration the consolidation of the data to a simple statistic: for those individuals who were given L-MTP-PE , was their survival longer than the control group? It appears from the most recent publications that the answer is a statistically significant “yes.”
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