DNDN and FDA Response
Through my readings of various blogs and message boards, and even CNBC, has stated today’s news from the FDA was ‘good’ news. I guess it can be viewed as ‘good’ when the FDA’s previous uncertain remarks become certain. This result was expected, and it was one of the first assumptions management gave during their conference call earlier in the month. If the interim data on survival is positive (as described in the SPA - Special Protocol Assessment), the FDA most approve the drug. However, the interim data will not be ready until 2008 (probably the 2nd half).
In my opinion, the only reason it is positive is because the FDA gave certainty to the situation. I am hard pressed calling today’s development positive as I still strongly believe the FDA short changed the company (and Prostate Cancer patients) by not giving it Conditional approval from the data already in hand. The fact that there is now certainty gives DNDN the ability to partner with a big boy, and have some kind of leverage. I hope management does partner, but over the three years I have been following this company the one thing I recognize is Gold’s stubborness. This makes me have uncertainty as to whether or not DNDN will partner.
If Gold and management decides to ‘go at it alone’, they will need to do a secondary, and the stock can most certainly see the 4-6 dollar range again, as we await the data. If management decides to partner DNDN can very well see 15. The cash infusion, and more importantly, the validation from a Big Boy (and their FDA lobbying abilities) will give tremendous confidence to the street about Provenge. (In other words, DNDN needs to partner.) Today’s development is a fire-fly’s light in a very dark abyss for the sole fact a partner can arise. If they partner, that light will get brighter and larger.
