Dendreon Corp fka DNDNQ

[prophet_of_profit]

Interim Look Strategy - a Different Approach

(I have posted this on IV earlier and I didn't receive any comments)

ASSUMING that DNDN can re-negotiate the terms of the interim look, I was thinking about an approach that differs from the "the higher alpha allocated to the interim look - the better" - I am actually thinking that it may be better for DNDN to allocate a very LOW alpha for this look, for example, a threashold of p=0.0001, thus keeping the entire 0.05 alpha for the final look. Obviously, in this case, the interim look will NOT be stat-sig, but the major merit here is that we minimize the risk that Provenge will not be stat-sig at the final look (2010) while we obtain an "official observation" at the data. The value of this "observation" is that it would show the FDA/BigPharma the TREND of the data - and we can assume that if the data has a p-value close to 0.05 the final-look WILL most likely be stat-sig. Then, the following scenarios may occur:

1. The FDA will be under MORE pressure to "conditionally approve" Provenge based on the "trending" data that was "observed" (on top of the existing 01/02A data), knowing that it is nearly certain that the final data is going to be stat-sig.

2. BP, when seeing the data, will find it nearly riskless to partner with DNDN. BigPharma will pay a significant upfront fee to DNDN for (US/RoW?) rights for Provenge, and this cashflow will enable DNDN to survive thru 2010/11 (without a secondary) AND would be sufficient to launch clinical trials for other cancers. Moreover, "our" BP partner will know how to apply more pressure at the FDA to find "a solution" to launch Provenge based on this interim data (back to #1 above).


Unfortunately, as we learned, DNDN cannot cross the goal line (approval) by itself in light of the VERY strong defensive line (CDER - oncologists - Sanofi - HFs) -->> DNDN will need a STRONG partner, and I would prefer having the BP partner before a dilution while maximizing the chances that Provenge will be approved, afterall.


Comments?