FDA decision scheduled for Nanosphere and Advanced Life Sciences (NSPH, ADLS, INO)

In the first quarter of 2009 Nanosphere, Inc. (NSPH) filed a de novo 510(k) submission for a hereditary hemochromatosis (“HFE”) genetic test. Mutations of this HFE gene are the leading cause of an iron overload disease. Nanosphere’s test to detect these mutations will help people with NSPH, since once the mutation is detected it is easily treated. Nanosphere says in their recent 10K SEC filing that approximately one in every 250 people of European descent has the disease and 31 of those people have some sort of HFE mutation. So keep an eye on Nanoshpere Inc and their genetic test today. Today, Friday July 31 2009 is the 6 month estimate of when the FDA decision is anticipated.

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!