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[piccooar]

Thanks! I will check them out. Better than the garbage I've been hitting and missing with today.

[dtonesworldwide]

anybody look at ANX?

[batya103]

Hi guys,

Here is new new updated list of Biotechs from Mr. Havrilla.

FDA Calendar Updates: TRIB Awaiting Two ResponsesShare
June 10, 2009
Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following additional categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.
SkyePharma (UK: SKP.L) (US: SKYEF.PK) has a pending NDA for a new asthma drug, Flutiform, which is the Company's most important pipeline product. On 5/22/09, SkyePharma announced that the NDA was accepted for review by the FDA and noted that the regulatory review timeline for asthma treatments is typically longer than the standard 10-month PDUFA decision deadline of 1/23/10.

On 6/9/09, SkyePharma provided info on FDA communication in the form of a 74-day letter which confirmed that the NDA is sufficiently complete to permit a review. However, the FDA has given preliminary notice of potential review issues which the Company stated will likely require additional clinical work to provide more data on Flutiform dosing. The potential FDA review issues are not expected to have an impact upon the development of Flutiform for Europe or Japan.

Par Pharma (NYSE: PRX): On 6/10/09, MonoSol Rx, announced that the new drug application (NDA) for ondansetron orally dissolving film strip (ODFS) has been accepted for review by the FDA with an expected PDUFA action date during 1Q10. Ondansetron ODFS was developed using MonoSol Rx's proprietary PharmFilm technology to deliver the anti-emetic therapy ondansetron in a thin film strip that rapidly dissolves on the tongue. MonoSol Rx and its partner Strativa Pharma (the proprietary products division of PRX) are seeking FDA approval of ondansetron ODFS for the prevention of nausea and vomiting associated with highly- and moderately-emetogenic chemotherapy, radiotherapy and surgery.

On 6/10/09, Watson Pharma (NYSE:WPI) announced that it filed an Abbreviated New Drug Application (ANDA) with the FDA seeking approval to market its guaifenesin/pseudoephedrine extended-release 600mg/60mg and 1200mg/120mg tablets prior to the expiration of patents owned by Reckitt Benckiser (LON:RB) (PINK:RBGPF) for Mucinex D. Reckitt Benckiser filed suit seeking to prevent Watson from commercializing its products prior to expiration of U.S. patent numbers 6,372,252 and 6,955,821.

Reckitt's suit was filed under the provisions of the Hatch Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA for up to 30 months or until final resolution of the matter before the court, whichever occurs sooner. Based on available information, WPI believes it is the first applicant to file an ANDA for a generic version of Mucinex D and, should its product be approved, may be entitled to 180 days of generic market exclusivity.

NeurogesX (NASDAQ:NGSX): On 6/10/09, NGSX announced that the FDA agreed to its proposed study to evaluate Qutenza in patients with post-herpetic neuralgia (PHN) following pretreatment with an FDA-approved topical anesthetic. As part of its ongoing NDA review, the FDA wants to determine whether pretreatment with an FDA-approved topical anesthetic would provide similar tolerability to the topical agent used as a pretreatment in the clinical development program. The NDA is supported by clinical studies of Qutenza which was applied after a 60-minute pre-treatment with an over-the-counter (OTC) topical anesthetic.

The study protocol involves enrolling about 20 patients with PHN to receive the Qutenza patch application after a 60-minute pretreatment with an FDA-approved topical anesthetic (2.5% lidocaine / 2.5% prilocaine). Based on the expected short-term nature of the study, NGSX believes that it could potentially complete enrollment, analyze the data, and submit an NDA amendment prior to the assigned PDUFA date. Submission of this amendment during the review cycle may result in an extension of the PDUFA date (likely to be a minor three-month delay from the current PDUFA action date of 8/16/09).

Trinity Biotech (NASDAQ:TRIB): On 3/10/09, TRIB provided the following update on the Company's new haemostasis (blood clotting) analyzer, Destiny Max, which has already been launched in markets outside the US. TRIB announced the submission of a 510(k) to the FDA on 12/23/08. TRIB expects to receive clearance and launch the Destiny Max high throughput coagulation analyzer in the US market toward the end of 2Q09.

On 3/9/09, TRIB announced the start of CLIA trials for its TRI-stat point-of-care HbA1c product, which is designed to measure HbA1c to assess a patient's average blood sugar control over the previous 2-3 months. Utilizing a patented boronate affinity and two-phase optical system, together with a simple, fully automated, plug-and-play instrument design, TRI-stat offers highly accurate results in minutes while eliminating the need for refrigeration required by three competing products. TRIB provided guidance that the trial would take about 4-6 weeks to complete at four locations at which point the data will be submitted to the FDA for CLIA approval.

Disclosure: Long TRIB.

[batya103]

Quick update on GNBT. Apologize if somebody put it already.

Generex Biotechnology Corporation (Nasdaq:GNBT) today announced that all of the 8% Senior Secured Convertible Notes issued by the Company on March 31, 2008 have been satisfied in full and no longer are outstanding.
As a result of the satisfaction of the notes, $3,000,000 in cash collateral provided as security for the Notes will be returned to the Company.

About Generex Biotechnology Corporation

Generex is engaged in the research, development and commercialization of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist(tm) device. The Company's flagship product, oral insulin (Generex Oral-lyn(tm)), which is available for sale in India and Ecuador for the treatment of subjects with Type-1 and Type-2 diabetes, is in Phase III clinical trials at several sites around the world. For more information, visit the Generex website at :: Generex Biotechnology Corporation ::.

[zwaffelaar]

Originally Posted by batya103 Quick update on GNBT. Apologize if somebody put it already. Generex Biotechnology Corporation (Nasdaq:GNBT) today announced that all of the 8% Senior Secured Convertible Notes issued by the Company on March 31, 2008 have been satisfied in full and no longer are outstanding. As a result of the satisfaction of the notes, $3,000,000 in cash collateral provided as security for the Notes will be returned to the Company. About Generex Biotechnology Corporation Generex is engaged in the research, development and commercialization of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist(tm) device. The Company's flagship product, oral insulin (Generex Oral-lyn(tm)), which is available for sale in India and Ecuador for the treatment of subjects with Type-1 and Type-2 diabetes, is in Phase III clinical trials at several sites around the world. For more information, visit the Generex website at :: Generex Biotechnology Corporation ::.

its already in the GNBT thread

[Kordoyn]

Watch IGNT today. They were down heavily yesterday, and got some good news last night. It'll most likely rebound back to the 0.015 range.

[mahmissa]

HGSI moving this morning.
Human Genome Sciences Reports Positive Long-Term Data for BENLYSTA(TM) (Formerly LymphoStat-B(R)) in Patients With Active Systemic Lupus Erythematosus

Superfly already posted a thread about HGSI

[riches2rags2]

Good morning Kordovn,

Thanks for the heads up!

I read the PR, and checked out the company's website, and it looks to be all good!

Thanks again, and have a great day!

[Dognamedabu]

Originally Posted by mahmissa HGSI moving this morning. Human Genome Sciences Reports Positive Long-Term Data for BENLYSTA(TM) (Formerly LymphoStat-B(R)) in Patients With Active Systemic Lupus Erythematosus Superfly already posted a thread about HGSI

HGSI is up almost 50% this AM. Thanks again Superfly~!

[schwi105]

Originally Posted by Kordoyn Watch IGNT today. They were down heavily yesterday, and got some good news last night. It'll most likely rebound back to the 0.015 range.

I sold the rest of my shares at 0.015 on market open yesterday thinking it would plummett. It would have been fun to play the 0.008 support to 0.01 resistance range following the dip though . Anyways, thanks for the heads up. I will keep an eye on it today and maybe jump back in for a few shares if I like what I see. Good luck on this one if you get in. I still think there is much upside. The stock is still up 400% over a two-day period. I think a healthy pullback was necessary yesterday. Keep an eye out.

Darin