Seven Trading Days out from the ODAC. As we head into the home stretch to the ODAC, TLON is looking very good. The briefing docs will likely be released on the 19th. Having been through a few of these, the tone of the documents is likely to be negative. That said, it is a matter of degrees, and if there aren't any extremely negative comments or questions regarding safety, efficacy, or trial design, it will likely be received as a positive and the stock is likely to move even higher.
The next thing to for is the panel vote. Again, if it is overwhelmingly positive, or unanimous, the stock is likely to soar even more. The other thing this would do, is significantly increase the odds that the FDA would approve Talon's drug before the PDUFA date IMO. When you put together an SPA, accelerated review, and an overwhelming positive committee vote I think the FDA could act sooner rather than later. Although they didn't face a committee, you can look at what the FDA did with Curis' drug for metastatic BCC as an example. One possible hitch in the analysis above would be the requirement to enroll the first patient in the PIII trial before approval.
If the panel vote were to be close to evenly split, I think we see a sell-off as the uncertainty continues until the PDUFA arrives.
All that said, the data from the trials looks very positive, and the population with this type of cancer is significantly under-served so I'm bullish on the prospects. I plan on holding through the ODAC/PDUFA/approval or $5 whichever comes first.
GLTA,
Murocman
