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Epicept Corporation (OTC:EPCT) announced on Tuesday that the European Medicines Agency [EMA] considers the company's post-approval commitments for Ceplene fulfilled. Originally the agency had required Epicept to conduct an additional confirmatory Phase III trial evaluating Ceplene with low-dose interleukin-2 (IL-2) versus a comparator arm of either no treatment or IL-2 alone, but the EMA ultimately agreed with a panel put together to assess the situation and decided that such a trial was not feasible.

Epicept continues to enroll patients for a separate ongoing post-approval trial with an estimated completion date of sometime in 2011.

Also of note from Tuesday's press release, President and CEO of Epicept, Jack Talley, indicated that the company was on track to file an NDA with the US FDA during the present quarter.

Because of this company's history of missing projected timelines, it's always a good idea to keep a skeptical eye with EPCT, meaning news isn't news until the press release hits the wires, not when the CEO says it's going to happen. With that being said, however, it looks like the Ceplene front is moving smoothly along after the long wait for a partner and the fact that the product is gaining acceptance in the medical community can only bode well for future sales and marketing.

It would be asking for too much to expect that Ceplene could turn into a blockbuster, however, but European sales over the course of the next year or two could be enough to support ongoing and future clinical trials for the pipeline, in my opinion, especially if the company receives a positive approval outcome in the United States.

I'd gone sour on EPCT in the past, but the recent developments - including a post-split drop in share price - have me looking at EPCT as a good mid to long term play with a decent risk/reward profile.

Disclosure: Long EPCT.

Source: Epicept: Good Play in Light of Recent Developments