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Biotech Regulatory Events (Non-PDUFA) - Snapshot from AndrewNava.com

|Includes:MSTX, Perseon Corporation (PRSN), SRPT

Below is a short list of regulatory-related events (non-PDUFA) from AndrewNava.com, a biotechnolgy and pharmaceutical database covering more than 290 publicly-traded companies and over 1000 profiles of approved and development-stage drugs, devices and diagnostics.

Regulatory Catalysts (non-PDUFA)

Adventrx Pharmaceuticals (ANX)

ANX is expected to discuss its refuse-to-file letter for its ANX-530 (vinorelbine emulsion) NDA with the FDA. On March 31, ANX received a refuse to file letter stating that the data included in the December 2009 NDA submission from the intended commercial manufacturing site was insufficient to support a commercially-viable expiration dating period.  No clinical or nonclinical issues were identified.  Timing: Last week of April

BSD Medical Corporation (BSDM)

On March 22, 2010, BSDM filed its 510K for the MTX-180, the company's MicroThermX Microwave System for soft tissue ablation.  The FDA typically has 90 days to respond.  Of note, BSDM's BSD-2000 has a pending HDE marketing approval for for cervical carcinoma.  The FDA has asked for questions relating to the device back in November 2009, but no updates have been provided since then.
Timing: 2Q10 (MTX-180), BSD-2000 (unknown)

AVI BioPharma (AVII)

AVII stated in its recent 10-K that it has completed the necessary preclinical GLP work for AVI-4658 and expects to submit its response to the FDA in 1H10 (now 2Q10).  The FDA put a full clinical hold on the AVI-4658 IND in 2009 requesting a set of Good Laboratory Practice (NYSE:GLP) compliant preclinical studies. A Phase 1/2 UK study in Duchenne muscular dystrophy patients is currently ongoing.  No U.S. patients have yet been treated with AVI-4658.
Timing: Submit data to FDA in 2Q10

For more regulatory events or to learn more about the companies and programs above, please visit andrewnava.com


Disclosure: No Positions

Stocks: PRSN, SRPT, MSTX