The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.

1.) Discovery Labs (DSCO) received a Complete Response Letter (CRL) today from the FDA for Surfaxin (lucinactant) in the prevention of Respiratory Distress Syndrome (RDS) in premature infants. The news today represents the fourth time the agency has declined to approve Surfaxin and requested additional information since the most recent approvable letter in May 2008.

The CRL from the FDA focuses primarily on certain aspects of a Surfaxin biological activity test (BAT, a quality control stability and release test) that must be addressed before the NDA can be approved. DSCO believes that it has already submitted the necessary data in response to the questions raised by the FDA in the CRL today and no questions were raised regarding the Phase 3 clinical trials, drug substance impurities, and the manufacturing process for Surfaxin.

DSCO plans to seek an end of review meeting with the FDA to be scheduled as soon as possible and believes a 2009 approval for Surfaxin is still feasible, pending a successful outcome from the meeting. Other topics in the CRL included the need for DSCO to tighten one drug product specification, which the Company states can be readily implemented. The CRL also outlines routine requests to update safety and other information in the NDA and the FDA has approved the trade name Surfaxin.

Despite the share price plunge in DSCO today, the trading pattern over the past few months provides an excellent example of a low-risk trading strategy for pending new drug decisions at the FDA for small-cap companies. Below is the strategy I outlined for trading DSCO in early January in a Seeking Alpha article:

. . . DSCO presents a model trade on a pending FDA decision at this time since it will likely enjoy a run-up in share price from current levels around $1.20 as the decision date nears. If DSCO experiences the bump in price, simply let the profits ride through the decision or just book all of the gains for a lower risk, lower reward trade on the expected increase in share price volatility heading into mid-April. . .

Since DSCO traded as high as $2.40 per share last week, this trading strategy would have been very successful with as much as 100% gains with very little risk since the stock price increase occurred ahead of the expected PDUFA decision date deadline. If you missed the opportunity on DSCO, check out my article on 12 extreme FDA trades on pending new drug decisions for some ideas.

2.) Impax Labs (IPXL) announced the start of a Phase 3 clinical trial (APEX-PD) for IPX066 in patients with mild symptoms of Parkinson's Disease based on encouraging interim data from a Phase 2 trial. IPXL also clarified the FDA requirement for pediatric studies of its investigational medication IPX056, which is an extended-release formulation of baclofen. Baclofen is a widely used muscle relaxant available in generic forms, but IPXL is looking to improve patient convenience through less frequent dosing in their proprietary formulation.

Instead of being required to conduct pediatric studies prior to approval, the FDA will allow IPXL to submit a proposed pediatric development plan for IPX056 with the NDA in order to avoid delaying the review and approval of IPX056 for adults. IPXL plans to finalize the second Phase 3 clinical trial evaluating IPX056 in the treatment of spasticity in adult patients with Multiple Sclerosis, with a goal of starting the trial in late 2009 or early 2010 with a NDA filing expected during 1H12.

Disclosure: No positions.