ImetelChat

EMA granted fast track to IMET in '15..... IMO approval for MF will come from them before the FDA.

Gwikley, I recall (from memory only) the EMA granting orphan status but not fast track, can you please post a link? The stock appears to be recovering nicely, it would be wonderful if there was EMA support. Thanks bp

My apology. You are correct. Fast track, no. Orphan status, yes.
Blinded by wishful thinking, I suppose.

Gwikley, I appreciate your enthusiasm. Might be worth a gander at hunts musings on confirmation bias!

Respectfully, may I ask your opinion why would there be a chance of approval when in fact Phase 3 in MF is not even certain and remain to be decided.

karagozoglu12345 wrote: ↑

Sat Mar 23, 2019 11:18 pm

Respectfully, may I ask your opinion why would there be a chance of approval when in fact Phase 3 in MF is not even certain and remain to be decided.

+1. We've been talking about early approval in MF for years... but Scarlett says there won't even be a "decision" as to whether to do an MF Phase until Q3.

The EU does have fewer drugs for MDS. But to assume that they would skip Phase 3 for that either doesn't make sense... the bureaucrats don't lose anything from delay, only the patients do.