Delcath Systems (NADSAQ:DCTH) continues to trade well-above average volume Tuesday, ahead of the FDA’s decision on the company’s recently submitted New Drug Application (NDA) for CHEMOSAT. Traders have run the stock up 37% since the beginning of October on excitement over the potential for U.S. regulatory review, which could come as early as the end of the week. In mid-August, DCTH submitted the NDA for CHEMOSAT with a request for Priority Review, which would shorten the regulatory review period to six months. The FDA is required to respond within 60 days if the NDA will receive Priority Review, setting an acceptance date of October 14th should the decision return positive. That being a Sunday, however, means the announcement could come Friday, or be delayed until Monday. In the case of a standard acceptance, the FDA must respond within 74 days, by October 28th. Either way, traders have had solid timeframes to move ahead of the decision. Momentum is likely to last into the end of the week, and into Monday if the FDA has not yet announced a decision, but holding through Friday or the weekend is risky. Investors wait with bated breath, and a negative Priority Review decision could send the stock reeling from its current highs.
CHEMOSAT is a hepatic chemosaturation system, and is already approved in the E.U. The system has had a slow sales ramp since its European approval in April of 2011, although providers have consistently expressed interest in the product. Shares are up 3% in pre-market trading on Tuesday.