A little caution..., page-11

"The talk of FTD enabling this to go direct to market "avoiding phase 3 trials" is very much NOT the case."

The FDA is a stickler for safety and health.

This is often the bane of the biotech investor, but in nnz2566's case it is our friend.

Retts is a serious condition. Young people are dying early because of it. There is no treatment.

nnz2566 has demonstrated a positive effect for Retts sufferers. nnz2566 has been proven to be safe, and has undergone many safety studies and trials.

Hence for the fda it's quite an easy decision. No treatment means suffering and probable early death. nnz2566 is safe and offers a possible treatment.

The fda created the breakthrough therapy designation because it is ethical to offer a possible treatment for a serious condition where no treatment in available as soon as possible. nnz2566 is unusual for BT candidates as it has such a good proven safety record, hence there is no strong valid reason not to make it available to sufferers as soon as possible.

As somebody else mentioned, the retts lobby groups are very vocal and active in the US too.

All imho.