richard,
The company addressed the data question. As has been mentioned it was based on a discrepancy between "evaluable" and "intent to treat" differences. On an "evaluable" basis, they showed improvement. The real problem, I think, was small numbers that couldn't establish statistical significance. Had they had larger numbers in the study, they feel they could have established their case. I got the sense they felt the ODAC committee had reneged somewhat on an agreement with the FDA to accept small numbers, use the evaluable cases rather than intent to treat, and consider the overall improvement profile because it is a life threatening disease.
My sense is that there is a good chance they will get approval with a supplemental submission of data. They also indicated that the results of their other DepoCyt studies-- lymphoma & leukemia -- were stronger. At this point I think the risk/reward situation is tilted heavily toward the reward side. All the negatives are pretty much factored in, but few of the positives. The chances of doubling or perhaps tripling the share price from here on any good news -- a new partnering announcement, plans to submit additional data to the FDA, good DepoMorphine results, etc.--seem good. The combination of bad news and a bad market day has probably combined to do about as much damage to the price of DEPO shares as we're likely to see, especially given the visibility of silver linings.
Baird
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