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Osiris (OSIR) Swissmedic Rapid Authorization Procedures For Prochymal Review

Prochymal® (remestemcel-L) will be evaluated under its Rapid Authorization Procedures

OSIR has been notified by Swissmedic, the Swiss agency responsible for the evaluation of drugs, that Prochymal® (remestemcel-L) will be evaluated under its Rapid Authorization Procedures. This designation, also known in Switzerland as Fast Track, typically cuts the evaluation period for promising new drugs in half.

Swissmedic approved the use of the Rapid Authorization Procedures following an initial review of summary clinical data for Prochymal used for the management of acute graft-versus-host disease (GvHD). Use of the Rapid Authorization Procedures is only permitted if the clinical data demonstrates a high potential for benefit for a severe, disabling or life-threatening disease, and where no alternative treatment option exists.

The Bottom Line: Definitely an … Actionable release … As a result of this decision, Osiris intendeds to promptly submit the full Common Technical Document to Swissmedic in the electronic or eCTD format to facilitate review. OSIR closed UP 9/27 at $10.24 and should be UP upon the open! Prochymal is truly an off-the-shelf stem cell product that is stored frozen at the point-of-care and infused through a simple intravenous line without the need to type or immunosuppress the recipient. Prochymal is approved in Canada and New Zealand for the management of acute graft-versus-host disease (GvHD) in children and is available for adults and children in eight countries including the US, under an Expanded Access Program. Prochymal is currently in a P3 trial for refractory Crohn's disease and is also being evaluated in clinical trials for the treatment of myocardial infarction (heart attack) and type 1 diabetes.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.