Well, we are counting down now, 28 days or less, 28 steps or less, ’til we turn another bend in a treatment for Rett syndrome; the FDA’s time to respond to Neuren’s application for Orphan Drug Status and Breakthrough Therapy Designation can come any time now.
What would that mean? ….. Speed. Blessed, wonderful speed. It could shorten the time from trial to treatment by YEARS.
Here’s an example of the type of speed I’m waiting for….
Before NNZ-2566 or placebo..
It will mean the focus of the FDA as it guides the steps in the right order to further the development of Trofinetide (NNZ-2566)
Here’s the kind of focus I’m waiting for….
And the steps I can’t wait to see again…all in the right order
There are others for whom the road has been longer, others for whom the road has been too short, but if the FDA gives this sought after approval, all around the world, in every country, those of every religion, creed, and color will be united as we all turn this bend together.
For more information about the FDA programs….. FDA.gov