About Santarus

@@CalendarRight@@ Santarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by gastroenterologists and other physicians. The company’s current commercial efforts are focused on ZEGERID® (omeprazole/ sodium bicarbonate), which is indicated for the treatment of certain upper GI diseases and disorders, and on GLUMETZA® (metformin hydrochloride extended release tablets), which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Santarus is also developing two late-stage lower GI product candidates, budesonide MMX® and rifamycin SV MMX®, for the U.S. market. Budesonide MMX is being investigated in two multicenter Phase III clinical trials for the induction of remission of mild or moderate active ulcerative colitis. Rifamycin SV MMX has been investigated in a Phase II clinical program in travelers’ diarrhea. More information about Santarus is available on the company’s Web site at www.santarus.com.

@@CalendarRight@@ About Paradigm Medical Industries, Inc.

Paradigm Medical Industries, Inc. develops, manufactures, sources, markets and sells ophthalmic surgical and diagnostic instrumentation and related accessories, including disposable products. The Company’s surgical equipment is designed for minimally invasive cataract treatment. Its cataract removal system, the Photon laser system, is a laser cataract surgery system designed to be marketed as the next generation of cataract removal. The Company’s diagnostic products include a P2000 pachymetric analyzer, a P37 Ultrasonic A/B Scan, P40, P45 and P60 UBM Ultrasound Biomicroscopes, a P37 A/B Scan, two perimeters, the Blood Flow Analyzer, and the Glaid. The diagnostic ultrasonic products, including the P2000 pachymetric analyzer, the P37 Ultrasonic A/B Scan and the P40 UBM Ultrasound Biomicroscope were acquired from Humphrey Systems, a division of Carl Zeiss.

Disclosure: Long PDMI

Nuvo provided the FDA with supplemental information back in August that caused the FDA to extent its action date by three months to today.

About Covidien

@@CalendarRight@@ Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in four segments: Medical Devices, Imaging Solutions, Pharmaceutical Products and Medical Supplies. With 2008 revenue of nearly $10 billion, Covidien has more than 41,000 employees worldwide in 59 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.

About Nuvo Research Inc.

Nuvo is focused on the research and development of drug products delivered to and through the skin using its topical and transdermal drug delivery technologies. Nuvo’s lead product is Pennsaid, a topical non-steroidal anti-inflammatory drug (NSAID). Nuvo intends to leverage its skin-penetrating technologies to create a portfolio of topical and transdermal products targeting a variety of indications. Nuvo is a publicly traded, Canadian pharmaceutical company headquartered in Mississauga, Ontario, with manufacturing facilities in Varennes, Quebec and Wanzleben, Germany and a research and development Center in San Diego, California. For more information, please visit www.nuvoresearch.com. Pennsaid(R) is a trademark of Nuvo Research, Inc.

@@Adsense@@ I had a chance to speak with Pat Bannister, CFO, at NavStar who advised they were “waiting on important documents from the middle east”. When asked if these documents were an inked deal or contract he replied “it’s probably just a letter of intent”. I let Pat know that investor confidence is most likely going down when they tell the market 5-7 days for more details and we are now going on 22 days. Pat was not very reassuring and responded “well, it is what it is, and the CEO is traveling around”. Apparently we are now waiting for more information “sometime next week” but I am not holding my breath.

A letter of intent is not a signed contract and I am not sure if this would qualify as “Major Breakthrough” in the Middle East. A letter of intent is known to be a non-binding agreement, in fact many specifically state the letter of intent is intended to be non-binding and no legal obligation will arise until a real future agreement is made.

It will be interesting to see when NavStar will actually provide their update on this “Major Breakthrough” and I am very interested to see if this letter of intent will become an actual contract or if NavStar just has good intent.

About NavStar Technologies, Inc.

NavStar is focused on the creation of products and services that provide tracking and monitoring of vehicles and high value cargo, equipment, and other valuable and personal assets.

Jim Holmes, Lifeline’s CEO, said ”If we can proceed with an 510(k) filing, our best estimate at this time is that it could take four to six months, possibly longer, for the FDA to clear our 510(k) application. Once cleared by the FDA the First Warning Systemâ„¢ could immediately commence commercialization.”@@CalendarRight@@

The CEO sounded very confident in the progress they have made with the FDA, their testing process, and supporting information they supplied. He also went on to address some concerns regarding their reverse split of the common stock and went on to say;

“We’ve also received many questions concerning the prospect of a reverse split of the common stock. Even though the outstanding common stock is approximately 2.9 billion shares, we have no plans for a reverse split.”

Dealing with these FDA applications has proven to require much patience as we have observed many delays with the FDA in the biotech sector. Lifeline sure has come a long way and we look forward to a response from the FDA.

**UPDATE** 10/26/2009 4:58 PM PDT

More details after contacting Jim Holmes, CEO of Lifeline Biotech, to provide even further clarification of todays news. Jim Holmes has been in contact with their FDA consulting firm who advised the FDA is 30-60 days past the normal time expected to provide a response. The FDA will determine if their technology and testing of over 600 patients would meet the requirements for a 510(k). Jim went further to say that he expects a response on this by the “end of November” but its not guaranteed and its all in the FDA’s hands now. Jim has done everything he possibly can at this point including calling the FDA to get status but the “FDA will not say one word”.

If the FDA responds favorably and determines they would meet the requirements for a 510(k) application then it will take Lifeline and their FDA consulting firm “about one month” to prepare the actual 510(k) application. Once the actual application is submitted then it could take 4-6 months for it to be decided on but again it is all up to the FDA and it could be longer.

Aastrom Bioscience Inc has intended to request an oral hearing before the Panel within the timeframe provided by the NASDAQ, to avoid the delisting of the Company’s securities. Also, Aastrom has decided to request continued listing on the NASDAQ Capital Market based upon its plan for regaining compliance with the minimum bid price requirement. The Panel has the authority to grant Aastrom up to an additional 180 days from the date of Staff Determination letter to implement its plan of compliance. NASDAQ has further provided guidance to Aastrom stating that they will schedule the hearing within 45 days of the date of request filed by Aastrom.

Next , Advanced Life Sciences (ADLS) has a anticipated target action date for their FDA NDA (New Drug Application) of today, Friday July 31st. One of our knowledgeable stock market forum members at FavStocks.com managed to speak with ALDS. ADLS was asked about their drug and what the expected outcome is, their response;

“We don’t think that we are going to get a straight-out denial just because companies that get an advisory panel meeting very rarely get straight-out denials. The FDA is more along the lines of stating what we can do to get approval. So we don’t anticipate a denial, we think it will be more an approval or some form of complete response letter asking for additional clinical work or post-marketing surveillance.”

Although this may be a generic answer from the company it is a good sign they have shareholder communication and they sound confident in their drug. Plus it helps that we know that statistically 70%-90% of all drugs that get past Phase 3 trials and move on to NDA submission get approved. So the odds are in your favor.

To help you find the next big biotech stock waiting for FDA approval, we are giving away our FREE FDA Calendar today exclusively to our new forum members of the FavStock.com stock market forum. Some sites actually try and charge you $120 or more for an FDA Calendar! Here you can also talk about some of the hottest biotech stocks. We hope you find the next Inovio Biomedical Corp. (INO) which went up over 300% over night!

According to a conference call, Dr. Carter stated Ampligen has a 80% chance of approval and possibly higher since the drug is classified as a NMW (New Molecular Entity) for which no other treatments exists. Only time will tell, until then we continue to wait.

If Ampligen is approved this will be the first and only FDA approved treatment for CFS with a estimated market of about 4 Million people.

Let us know what you think about HEB on the FavStock.com stock forums. You will notice FavStocks.com stock market forums don’t have the usual pumpers, spammers, and trolls.

You can find information about Hemispherx Biopharma (AMEX:HEB) on the links below

Hemispherx Biopharma – HEB

http://www.FavStocks.com/forum