Tony WAIW + Little TI agree that if for some reason the FDA does...

Tony WAIW + Little T

I agree that if for some reason the FDA does not approve Trofinetide then the SP will drop like a stone
BUT
not to zero since we will still have NNZ2591 ....
SO
The main issue:--- In order to get a better feel for the "probability of straight through approval" let's look at from where in our submission and data could the negative result (if any) originate?
We have had no updates to tell us what we are learning from:--

• Open Label Lilac ... additional 52 weeks but many subjects must be well along this pathway perhaps at or near the end .. how many stayed but then dropped out? Any issues revealed
• Continued Access Lilac-2 ... what proportion of the subjects have stayed?
• Daffodil trial ... what was learned from this? Any issues revealed?
• There were references to diarrhea in some subjects versus constipation ... has this issue been addressed?

Have any doubts or issues been revealed which might cause the FDA concern?
Is our manufacturing process sorted?
Why are we not being told these things which I regard as being very relevant?
I know that you are not official spokesmen for the company ... but maybe you have heard something?
Would there be a presentation in the near future where I/we might be able to ask Jon directly?
regards

KB