Unbelievable...., page-23

I asked about the 6 month trial. "subsequently we agreed with Acadia and FDA to shorten the placebo period to 3 months.

Jimbo 74, it was already announced that this was a 3 month trial in February last year (04/02/19).


That’s confirmed we will get results from Ph3 at end of Lavender Trial.

Taureanbull - Yes, it is confirmation that we will get results from Ph 3 at the end of the Lavender trial but I can’t recall anyone suggesting it would be otherwise.


Therefore yesterday’s announcement becomes much more significant because we can apply for the PRV much sooner than many think.

Taureanbull - How so? The PRV can’t be applied for before the NDA is filed and then cannot be awarded until marketing approval is received.

Current Acadia expectation is that the Lavender trial will complete in October 2021 and the Lilac extension trial in October 2022. After the Lavender trial results come out, the submission package will need to be compiled before filing with the FDA. (This is not an overnight task. Starpharma’s CEO revealed that their NDA comprised 100,000 + pages.) Putting together an NDA can typically take 3-6 months months. Once submitted, with priority review, there is a 6 month wait for the FDA decision. That suggests to me that an FDA decision on both trofinetide and a PRV is unlikely to happen before H2, 2022.