It is interesting to think if the trial is successful (matching or beating the same results of previous) - we will be able to receive a voucher valued at anywhere between $100-300m.
We will have the option to sell the voucher to fund the next steps or part of the next steps alone by selling it OR speed up the approval by half a year.
What is the Pediatric Priority Review Voucher (pPRV)? •PRV system designed to incentivise private sector to develop new medicines for rare and underserved diseases •pPRVs may be awarded by FDA on approval of a new medicine for a rare pediatric disease, providing it is the first approval for that medicine •To be eligible for a pPRV, the drug must have been granted Rare Pediatric Disease Designation (RPDD) prior to filing for approval – ATL1102 has been granted RPDD •A PRV allows the holder to accelerate FDA review of any new drug application from ~12 months to ~6 months. For a high-value product, this acceleration is very valuable. The holder does not have to use the voucher on the drug for which it was originally granted •PRVs can be freely traded between companies. The current market price is in excess of US$ 100M
PRV info taken from company presentation.
ANP Price at posting:
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