DSCO - Discovery Laboratories, Inc. (NASDAQ Stock)

[thegreatgate]

Anyone else have Disco (DSCO) Fever?


Today's close: 48 cents on 3 million volume
A/H close: 71 cents (+48%) on 3.1 million A/H volume

News:
Discovery Labs and FDA to Meet On September 29, 2009 to Discuss Potential Path for SURFAXIN Approval
WARRINGTON, Pa., Sept. 10, 2009 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO) has received written notification from the U.S. Food and Drug Administration (FDA) that a meeting has been scheduled for September 29, 2009. This meeting will serve as a follow-up to the June 2 meeting with the FDA and the FDA's April 17 Complete Response letter. The objective of this meeting is to define the options available to Discovery Labs to resolve the remaining primary issue that Discovery Labs must address to gain U.S. marketing approval of Surfaxin(r) (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants.

At the upcoming September 29 meeting, Discovery Labs plans to discuss with the FDA a limited Surfaxin clinical trial design and whether conducting such trial, while simultaneously employing the fetal rabbit Biological Activity Test (BAT, a quality control and stability release test), could potentially address the key remaining requirement for Surfaxin approval. This approach was suggested by the FDA at the June 2 meeting as a way for Discovery Labs to increase the likelihood of gaining Surfaxin approval. In addition, Discovery Labs plans to review its ongoing quality improvement efforts, intended to further refine the BAT in accordance with Discovery Labs' continuing quality improvement initiatives, with the FDA.
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Daily Chart:

[Magn3tar]

I've been watching this stock fluctuate between .46-.51 and was thinking about playing it for a quick 10% gain. I'm looking for this to drive HEB up a bit as well today.

[BadThad]

LOLOLOL @ picture!

Great pick BTW, up 36% today!

[thegreatgate]

Got in right at the bottom for DSCO....low of the day 62 cents....last trade 81 cents

I blocked out the # of shares and price but here is where I got in:


Chart still @ noon today, broke through trendline on massive volume...close @ 75 cents or better would be nice:

[BadThad]

Did you take profit? I dump these pharma shares very quickly!

[thegreatgate]

Originally Posted by BadThad

Did you take profit? I dump these pharma shares very quickly!

I left the house around 2pm so I didn't see it hit the day high of 98 cents. But, in my account I couldn't sell if I wanted to cause I am out of my 3 daytrades.

I just started trading in my brothers account and got him in @ 63 cents and out @ 69 cents. It was a quick $145 for him but would have been about $650 profit @ today's close of 86 cents. So I am not happy about that trade. But oh well, he didn't have to do a thing to earn $145 today and I still have all of my shares.

....DSCO will need to drop about 28% on Monday to get to my 62 cent entry. I'd say there is still a decent chance of another mini-pop on Monday...51 million volume today was the all-time high for DSCO....

[thegreatgate]

Out @ $1.09....

[greencat]

DSCO looks like it may make another move.Holding the MA's well. If the macd turns back up it may make a huge move.

DSCO CHART

[paperchase]

Source: Discovery Laboratories, Inc.
Discovery Labs and FDA Establish Path for Potential Surfaxin Approval
FDA Supports Proposed BAT Optimization and Approach for Limited Clinical Trial
WARRINGTON, Pa., Sept. 30, 2009 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO) held a teleconference on September 29, 2009 with the U.S. Food and Drug Administration (FDA). The meeting established an approach to potentially resolve the remaining primary issue that Discovery Labs must address to gain U.S. marketing approval of Surfaxin(R) (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. The meeting focused on Discovery Labs' plans regarding optimization and final method validation of its fetal rabbit Biological Activity Test (BAT, a quality control and stability release test) and a proposed limited Surfaxin clinical trial design, which would simultaneously employ the newly-optimized BAT.

At the meeting, the FDA indicated that Discovery Labs' proposed program to optimize and validate the BAT is reasonable. The program is intended, among other things, to confirm that the BAT can adequately distinguish change in Surfaxin biological activity over time. As a result of the meeting, Discovery Labs believes that it has reached an understanding with the FDA and is confident that it will be able to optimize the BAT to the satisfaction of the FDA. Discovery Labs intends to employ the optimized BAT in conjunction with all of Discovery Labs' KL4 surfactant pipeline programs, including the potential limited Surfaxin clinical trial.

In addition, Discovery Labs received guidance from the FDA on its proposed limited clinical trial design. The trial design is intended to primarily assess a pharmacodynamic (PD) response following Surfaxin administration in preterm infants with RDS. This design was selected to address FDA requirements for Surfaxin approval while limiting trial expense and duration. The FDA indicated that a PD-based approach is consistent with their expectation for a limited clinical trial and also provided direction regarding trial design specifics. The final clinical trial design will be subject to FDA review following submission of a formal protocol. Discovery Labs expects to finalize a protocol and anticipates submitting it to the FDA in mid-fourth quarter of 2009.

W. Thomas Amick, Chairman of the Board and Chief Executive Officer of Discovery Labs, commented, "We are pleased with the guidance received and outcomes obtained from our interaction with the FDA. This guidance provides a viable option for Surfaxin and meaningfully supports advancing our pipeline initiatives to potentially address a broad range of respiratory diseases such as RDS, Acute Respiratory Failure, Acute Lung Injury and Cystic Fibrosis. We look forward to continued productive dialogue with the FDA.

"Our most advanced programs from our KL4 surfactant pipeline, Surfaxin, Surfaxin LS(TM) and Aerosurf(R), have the potential to greatly improve the management of RDS and to redefine the RDS market. Our top priority is to secure strategic alliance partners and access capital to advance our pipeline and build shareholder value. As we move forward, we will take into account further interaction with the FDA and make strategic assessment, together with existing and potential new partners to determine the appropriate level and timing of Surfaxin investment and to maximize the value of our KL4 pipeline for RDS."

[greencat]

DSCO has a trendline that if broken could be a nice move up.

DSCO Chart