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Welcome & BioMimetic Therapeutics

posted May 10, 2011, 7:03 PM by Bryce Istvan   [ updated May 14, 2011, 6:04 PM ]
First, I would like to welcome you to this site. Hopefully you will find the information provided useful.

Jumping to biotech, the biggest loser on the Nasdaq today was BioMimetic Therapeutics (BMTI). In a classic demonstration of the sensitivity of small cap biotech companies to FDA statements, BioMimetic fell 35% today on news out of the FDA's Orthopaedic and Rehabilitation devices panel that there were serious concerns about the company's Augment Bone Graft.

"[The] FDA recognizes that the sponsor has shown potentially a marginally non-inferior study (albeit if the panel agrees with the use of mITT vs. the ITT). However, FDA still has clinical concerns with the safety and overall risk/benefit of the device at this time, primarily due to the unanswered question of safety in regards to the potential for cancer formation versus an unproven benefit in the current standard for care."

The full set of meeting materials can be found here.

The panel will meet with BioMimetic on Thursday, May 12th and provide its recommendations at that point.

On May 9th BioMimetic reported its results for Q1 2010 with an $8 million loss on just $400,000 in revenue, mostly from royalties. The Augment bone graft and the Augment injectable product which is due to enter into full clinical trials by the end of this year are the company's only products. Without approval from the FDA or the EU (where a decision is expected sometime in 2012) its prospects are bleak.