FDA Calendar Updates, New Extreme Trades Print E-mail
Thursday, 23 July 2009 15:37

Below is a summary of updates and new extreme trades included in the BioMedReports.com FDA Calendar, which includes a database of 280 entries as of 7/23/09. 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 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 clinical trial results.

On 7/23/09, Peplin (ASX:PLI) announced the initiation of its second non-head Phase 3 clinical trial to confirm the efficacy and safety of PEP005 (ingenol mebutate) gel for the treatment of actinic (solar) keratoses (AK), a common pre-cancerous skin lesion, when applied to non-head locations, which include the trunk and extremities.This second pivotal Phase 3 trial for non-head locations, known as REGION-Ib, is designed to replicate the recently completed REGION-I trial and confirm the results of PEP005 gel.

In addition to the REGION-Ib trial on non-head locations, Peplin recently completed enrolment in its REGION-IIa and REGION-IIb trials for head locations, which include the face and scalp, and announced the results from its REGION-I trial, the first Phase 3 for non-head locations, earlier this year. Peplin will complete their Phase 3 clinical trials for AK by the end of this year and plans to file a New Drug Application in mid-2010. On 7/8/09, Peplin announced the completion of enrolment of its two Phase 3 clinical trials for the use of PEP005 gel to treat AK, which include the face and scalp. These Phase 3 clinical trials are referred to as REGION-IIa and REGION-IIb and enrolled approximately 250 patients each. Peplin plans to announce the REGION-II trial results during 4Q09.

On 5/15/09, INVO Bioscience (IVOB.OB) provided the following update on obtaining FDA marketing clearance for its fertility technology. INVO technology assists infertile couples in having a baby. In-vitro fertilization (IVF) is an effective treatment option for most infertile couples, and the Company's patented and proven INVOcell technology is a low cost alternative to IVF that is much simpler to perform. INVO uses a device, the INVOcell, which is currently priced at $75-225 to distributors in developing countries and $125-300 in Europe and U.S.

While IVOB penetrates the infertility markets in Europe, Canada, and select developing countries, the Company has also completed the first step for medical device companies who manufacture Class 2 devices with the filing of a Premarket Notification 510 (k) submission with the FDA. Technically, the FDA does not "approve" Class 1 and 2 medical devices for sale in the U.S. as the Agency issues "clearance" for them to be sold and marketed. IVOB hopes to receive U.S. marketing clearance by 2010 upon completion of its clinical trial.

On 7/23/09, Celgene (NASDAQ:CELG) announced that a clinical trial known as MM-015 showed a highly statistically significant improvement in progression-free survival for patients taking Revlimid as a first-line treatment for multiple myeloma. The trial tested Revlimid in combination with the drugs melphalan and prednisone. Revlimid is currently approved for use with dexamethasone. Revlimid is currently approved for use in patients who have failed other therapies, and is currently used in the U.S. off-label in the first-line setting and CELG cannot market the drug for this purpose until approved by the FDA. CELG said results of the trial were originally expected during 2H09 and that the full data is not yet available for this study. Once the data is analyzed, CELG plans to meet with multiple regulatory agencies around the world.

On 7/8/09, Lifeline Biotech (LLBO.PK) announced that its First Warning Systems subsidiary completed a Series A private placement of $125,000. The promissory notes (due in mid-2010) are convertible into common stock of First Warning Systems. LLBO.PK stated that the initial funding provides the Company with important resources needed to move forward on its expected FDA filings. LLBO.PK stated that it is preparing for another round of financing in the form of a Series B private placement of common stock for up to $1.5 million, which is expected to fund the Company through the FDA process and clearance.

LLBO.PK has in the past year filed for a patent on the recent technological advancements of the First Warning System, which has achieved the capability of identifying and classifying tissue abnormalities of the breast with sensitivities (ability to identify) of 95-100% and specificities (verify) of 87-90%. First Warning Systems has retained a firm that specializes in FDA filings to assist in the preparation of its preliminary filing with the FDA, which is expected by the end of July.

Disclosure: No positions

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