FDA grants Fast Track Designation for PC Treatment

Because of you, the work towards effective treatments for PC continues. Please enjoy the following email and press release we received this morning from Wes Kaupinen, CEO of Palvella Therapeutics.

To Janice, PC Project team, and the broader PC community:

I’m thrilled to share with you this morning’s press release that the FDA has granted Fast Track Designation to Palvella for the advancement of PTX-022 (novel, high-strength rapamycin topical formulation, optimized for dermal targeting) for the treatment of PC. This milestone has its roots in the transformation that occurred at the FDA on April 6, 2018. The FDA’s views on, and understanding of, PC forever changed that day as the team at PC Project led PC patients from all across the country in passionately and courageously sharing their personal stories of living with PC with 42 FDA officials. Further instrumental to this milestone has been the unwavering clinical and scientific support from all of you, over many years, who have thoughtfully guided the TransDerm and Palvella teams in navigating through the significant, but surmountable, challenges that present when developing a therapy for a serious rare disease. A special thanks to the dynamic duo of James Valentine and Frank Sasinowski who have worked tirelessly to engage the senior ranks of the FDA in an effort to ensure that the voices of PC patients are heard at the FDA.  

While we have a long way to go to deliver on our shared objective of introducing safe, effective, and FDA approved treatments for PC, this recognition by the FDA nevertheless sets the stage for the acceleration of the PTX-022 program and other therapies with potential to significantly improve the lives of individuals with PC. Thanks to all of you for your continued personal and professional friendship to me and the Palvella team every step of the way.

Wes

http://www.globenewswire.com/news-release/2018/11/12/1649638/0/en/Palvella-Therapeutics-Announces-FDA-Fast-Track-Designation-for-PTX-022-for-Treatment-of-Pachyonychia-Congenita.html

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