EMA
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- Comments must be civil and on topic
- Back up claims with evidence/reasoning/sources (posting links is allowed)
- No commercials/harassment/spam
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- Posts: 1670
- Joined: Fri Jul 20, 2018 5:13 pm
Re: EMA
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
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- Posts: 1670
- Joined: Fri Jul 20, 2018 5:13 pm
Re: EMA
Gwikley, I appreciate your enthusiasm. Might be worth a gander at hunts musings on confirmation bias!
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- Posts: 61
- Joined: Wed Oct 03, 2018 12:48 am
Re: EMA
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.
Re: EMA
+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.karagozoglu12345 wrote: ↑Sat Mar 23, 2019 11:18 pmRespectfully, 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.
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.