Entremed (ENMD)

[RRGY2K]

Approval: It's really hard to know, and of course, the company has to be very cautious about speculating (clue: look at published business plans for future revenue projections).

First we need solid trial results in a sample big enough to be statistically significant. Smaller & slower efficacy results require larger samples, elapsed time from now: Between Zero (they already have it) and never, most likely to me to be about 12 months out, assuming the thread is already well in hand that's going to take us there (which I believe to be the case from the company taking the loan).

Then, the NDA needs to be filed with the FDA (Elapsed time: between zero (it's already been filed) and never. While this is man-years of work for the company, the elapsed time can be significantly compressed by working in anticipation of the trial result. Then there's the FDA approval cycle that can take 6 months to never. With a low toxicity drug for a fatal disease, hopefully they'll move quickly (for the FDA).

With slam dunk results, Gleevec was approved about 6 months after the trial announcement. This could happen for GBM at Duke, for example, if Panzem was shown to significantly increase the number of GBM patients who respond to Temodar or add to the expected length of their response. But slam dunk results are neither likely nor necessary for the drug approval process.

Right now, the company isn't given much for odds by the market. Every step along the way should improve the odds and reduce the risks, which should improve the market cap as expectations build. This process doesn't really end for a successful company either -- look at Celgene, or Pfizer, for that matter.

So the long answer is it's between 6 months and never, most likely in 18 months to 3 years if one of the current trials leads us to approvable statistics (all IMO, of course).