Market rollout of SkinTE continues to impress. 100% of product evaluators have initiated purchase agreements. Q3 revenues will be above consensus and above internal estimates.
The items cited during the on-site inspection are "non-final" observations and are part of the routine regulatory process. It has responded to these items and will continue to follow FDA guidance as provided.
The U.S. patent Citron cites as a "final rejection" is anything but. It has responded to the USPTO and its patent prosecution continues on the referenced application and as additional applications.
Its corporate governance has been strengthened for some time. The executives Citron cites are no longer associated with the company. Six of eight board members are independent. All eight were appointed in the past two years.
Previously: FDA deals blow to PolarityTE - Citron (Oct. 18)
Previously: PolarityTE responds to Citron Research fraud claims (June 27)
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