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eicoman

08/08/14 10:59 AM

#18665 RE: nbm16yankees #18664

Vitaros is different formula, and it should be available in the USA by then anyway, not a consideration IMO

zmanindc

08/08/14 11:12 AM

#18668 RE: nbm16yankees #18664

If they receive approval for Ray-Va it then provides a chance to file for V approval under the 505b process. That process allows for approval of an already approved drug to treat a different condition. The company just has to provide safety and efficacy data. They can file because V is basically the same chemical composition as Ray-Va and just a different dose.