Discovery Laboratories, Inc. (DSCO)

Discovery Labs is another biotechnology company who does things I can't pronounce or spell so I should stay away. It has my attention due to FDA rulings that are due soon (April 17th). So if you're reading this after then I'm either a FOOL or a "fool" for following the pied piper. At this point it's drug to prevent respiratory distress syndrome (RDS) in infants has had several set backs due to manufactureability and delivery mechanisms. It's very difficult to deliver the right amount of a drug that is airborne, especially when your target is very, very, small! They have been working on the delivery mechanism and are ready to try again with the FDA. Normally I stay away from biotechs as the road is long and the FDA has the power to set things back by months or years or kill the product out right. In this case it was not the drug that was in question, but the delivery and dosage. The drug has it's 3rd approval letter from the FDA, but had a six month inquiry period rather than the two months that had been hopef for by investors. Favorable results and the biotech stock soars on $$ signs based on cryptic math or buyout opportunities, bad results or FDA in a bad move and the stock dives. In this case I put real money on Discovery Labs. Maybe my glasses are fogged from Dendreon this week.....
Betting for bio's at least is betting for the human side of things while hoping for the monetary gain!

I think they might have messed up enough to finally get their product to market

Slow climb should start in early April in anticipation of an April 17 decision. Lousy management will likely achieve FDA approval despite themselves.

Discovery Labs: Poised for Eventful End of Year

Discovery Labs (DSCO) is set for an active end to the year with a planned complete response to the May 1, 2008, FDA approvable letter for Surfaxin, which management has guided for submission by the end of September. The Company will provide impurity data and biological activity tests to the agency and expects the NDA re-submission to be classified as a Class I review with a 60-day decision deadline compared to the more lengthy Class II resubmission process of six months. At mid-year, Discovery Labs had cash and equivalents of $33.4M with an expected 3Q08 cash burn rate of $7M and a $60M financing facility in place.

With shares currently trading just below $2 and well off the panic lows of $1.29 per share in May, I would wait until the complete response is accepted by the FDA and classified as a Class I resubmission before buying shares ahead of another NDA decision date. If everything goes as planned, I would consider buying some shares ahead of the FDA decision date as the outstanding issues appear to be relatively minor and manageable without the need for additional time-consuming, costly clinical trials.

Currently all surfacant products require endotracheal intubation to administer. The DSCO product can be given in a nebulizer by a nurse. This eliminates a dangerous and time consuming procedure. As a pediatrician I think this is HUGE!

Junren told me to

finally

Finally getting Surfaxin approved by end of 08 or early 09 will double stock price in one day, but - on the other hand - failing to get it approved by then will half the stock price. Definitely not a sure thing, but given the apparent effectiveness and potential importance of Surfaxin for a variety of respiratory diseases in infants, children, and adults, and the recent progress towards final FDA approval, this stock is a pretty good bet. Check out the positive analyst reports on DSCO from S&P and Reuters (e.g., through Scottrade).

Likely to achieve FDA approval for Surfaxin with response to approvable ruling due in September and likely 60-day review by FDA.

It is only a matter of time for the approval of Surfaxin. The data requested by the FDA is merely to back-up the safety profile of the drug. This drug will serve as a model for the rest of the pipeline. With the increasing incidence of premature births, the drug's market can only grow.

Waiting for the good news!

Discovery has long been held back from releasing their franchise drug Surfaxin due to their struggles with getting an approval from the FDA. However, it would seem that they are confident that Surfaxin is near approval as they have recently secured financing through Kingston. Today DSCO delayed its response to the FDA and the stock went as low as $1.55. I see this as a great opportunity with two possible scenarios. 1: Surfaxin gets approved by late 08, early 09 and DSCO will start accumulating earnings in Q4 09 or 2: They will be bought out shortly after Surfaxin is approved.

all it needs is to get approved and then its over 5 a share

Well managed company that is about to have it's first drug approved by the FDA. They have already secured 3 years worth of continued existance and are well on their way.

This stock could provide a good entry point sometime in the next month - but I would wait until there is news.

SURFAXIN

This small healthcare drug discovery company is risky. There lead product is a surfactant which sucessfully treats lung problems for premature babies. This drug if it ever hits the market should make a real impact on every NICU in the country.

The drug should finally be approved in August. I hope to the price per share slowly climb and then have a smally jump when the drug finally gets passed by the FDA.

With approvable letter and few minor issues from FDA, this should be a win win stock

Two thumbs up!!!! Once the FDA approval finalize in few weeks, this stock will hit at least $4!!!!!!!!