EMA

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Gwikley
Posts: 31
Joined: Thu Aug 30, 2018 9:05 pm

EMA

Post by Gwikley » Wed Mar 20, 2019 4:35 pm

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

biopearl123
Posts: 180
Joined: Fri Jul 20, 2018 5:13 pm

Re: EMA

Post by biopearl123 » Wed Mar 20, 2019 7:46 pm

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

Gwikley
Posts: 31
Joined: Thu Aug 30, 2018 9:05 pm

Re: EMA

Post by Gwikley » Thu Mar 21, 2019 3:15 am

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

biopearl123
Posts: 180
Joined: Fri Jul 20, 2018 5:13 pm

Re: EMA

Post by biopearl123 » Thu Mar 21, 2019 5:29 am

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

karagozoglu12345
Posts: 52
Joined: Wed Oct 03, 2018 12:48 am

Re: EMA

Post by karagozoglu12345 » 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.

cheng_ho
Posts: 98
Joined: Sun Apr 03, 2016 11:27 pm

Re: EMA

Post by cheng_ho » Sun Mar 24, 2019 2:44 pm

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.

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