Awesome news indeed!! • PYC’s drug candidate for the treatment...

Awesome news indeed!!

• PYC’s drug candidate for the treatment of RP11 has today been designated a Fast
Track development program by the US Food and Drug Administration (FDA)
• The purpose of the Fast Track designation is described by the FDA as being ‘to
get important new drugs to the patient earlier’
• This drug candidate is now eligible for Accelerated Approval and Priority Review
along with a range of other benefits.

PYC Therapeutics Limited (ASXYC) today announces that the VP-001 program, the first
investigational drug candidate designed to address Retinitis Pigmentosa type 11 (RP11)
to progress to human trials, has received Fast Track designation from the US Food and
Drug Administration (FDA).

The Fast Track process is “designed to facilitate the development, and the review of drugs
to treat serious conditions and fill an unmet medical need” with Fast Track status “often
leading to earlier drug approval and access by patients”3.
Benefits of the Fast Track designation include:
• Increased frequency of meetings with the FDA to discuss the drug’s development
plan;
• Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met;
and
• The potential for a Rolling Review in support of a New Drug Application.

A reduced timeline to commercialisation is great for shareholders but even better news for people with RP11!
gltah