https://trailtoatexastrial.wordpress.com/The words we have been...

https://trailtoatexastrial.wordpress.com/

The words we have been waiting for have finally been written. It’s a couple of weeks later than our hearts were shooting for, but better late and the best it can be.

The highlight is the first paragraph:“Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for trofinetide for the treatment of Rett syndrome in adults and pediatric patients two years of age and older.”

We already knew that the Phase lll results met the endpoints. What we NOW know is that the Daffodil trial (ages 2-5) also met its endpoint and those ages are being included in the application.

We have here a tremendous gift. If all goes according to plan, when Rett syndrome is just starting to rear it’s thieving, ugly head- a doctor can give the results AND a prescription.

I know, I know…when does that mean approval? Or at least when will we know? The FDA has given Trofinetide several designations. Along with those designations comes the possibility of expedited review. The FDA has 60 days to review the application and accept it; they will let ACADIA know in 60 days if Trofinetide has been granted an expedited review.

Even still, as of right now, with or without expedited review, we have about the length of one pregnancy until we find out. That’s how I’m looking at it. We could be a couple months in already or just at the start, we’ll get confirmation in 60 days.“…trofinetide for the treatment of Rett syndrome in adults and pediatric patients two years of age and older.”

The future is almost here. Trofinetide is pounding its hooves in the hardened dirt of Never and breaking it; it is tearing that solid “packed against us” track up. Its strides are in precision- and it’s pulling away from the pack of naysayers. Phase l, Phase lla, Phase llb, won their races- now it’s Lavender, Lilac and Daffodil- all under the name- Trofinetide.

Thanks to all those who bet on those early races (Neuren and stockholders) and gave us this incredible moment in time. There’s only one more hurdle ahead. I think we’ve got this.