Targovax Receives US FDA’s Fast Track Designation for ONCOS-102 for Malignant Pleural Mesothelioma

February 16, 2021 Auto Bot Fast Track Designation, FDA, receives, regulatory 0

Shots:

  • The US FDA has granted FT designation for ONCOS-102 based on pre/clinical efficacy associated with broad immune activation observed to date
  • The designation is granted to therapies with the potential to address unmet medical needs in serious diseases and allows for more frequent interactions with the FDA to expedite clinical development as well as the regulatory review processes
  • The FT designation follows ONCOS-102’s ODD with both US FDA and EMA in the mesothelioma indication providing market exclusivity for 7 and 10yrs in the US and EU from the date of BLA grant

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Targovax

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