re: DOR - another biotech value ?
"dor met all secondary endpoints"
1. The new claim of a survival benefit in the phase II trial was neither a primary or secondary endpoint (see below).
2. The parallels between DNDN & DOR are remarkable (including the trial imbalance issue, like 9901 - see below ) - this will be talked about as their PDUFA dates will not be far apart (that is of course, if you believe BOTH companies).
3. DOR looks like it belongs among the Biotech Values of note - a sub $20m market cap, plus it just solved some of it's financing problems It still has an Amex listing problem, but that seems likely to be resolved (it was a $6m book-value issue). It's an Orphan indication, and the survival benefit seems clear enough, endpoint issue notwithstanding. The risk/profit profile is favorable, and I will be buying more on Monday.
"Since we missed our primary endpoint in the pivotal trial, the FDA has told us that a very high emphasis would be placed on our survival data. While the new preliminary Phase II survival results were not a prospectively defined endpoint, they are nonetheless supportive and corroborate the results from our pivotal Phase III clinical trial."
In fact, there was a higher proportion of high risk patients in the orBec® group which would be expected to put the orBec® arm at a disadvantage. In spite of this, orBec® was still the factor with the strongest statistical association with survival.
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