The old TIS tried to get our product approved through the EU, but got caught in that wall of bureaucracy. The EU and the BMA played pass the parcel for a while, not wanting to make a decision.
FTT (the phoenix of TIS) has gone for the more expensive but properly defined fda route (although this route is actually cheaper, as the old TIS use to burn through money).
FTT is much leaner compared to TIS and is getting there. The trial is moving. There have been some problems, but the company has addressed those issues and put in new sites to improve things.
The phase 2 results are what count, and they are coming. It's just a matter of time.
Until then, there's nothing more to say imho (unless something changes).
cheers
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