Link to EU ODD mtg kindly provided by Anne YMB

[biopearl]

http://www.ema.europa.eu/docs/en_GB/doc ... 212636.pdf

[cheng_ho]

Looks like there must have been some action at the EMA. Too bad they're so nontransparent, it usually takes a month to get the meeting minutes.

[Fishermangents]

And they are leaving out anything that is commercially sensitive.

[cheng_ho]

Now on SA they're saying the ODD application had nothing to do with imet. Just more random noise...

[biopearl]

Now Cheng, I believe you are confused. Try to take a deep breath and do serial sevens to be sure everything is working upstairs. The EMA documents of Sept 6th confirm a discussion of imetelstat. Taz simply made a mistake (he usually doesn't) and thought that an entry on a Facebook site was related to Imetelstat when it turned out not to be related to a different drug. It happens. The EMA ODD committee did discuss Imetelstat again as noted in the Sept 6th docs. bp

[scottmayhew]

This is what William was referring to:


Street_fighter
Comments (93) |+ Follow |Send Message
The EMA meeting yesterday had nothing to do with imetelstat. Another drug was applying for ODD for MF, where the only existing ODD designation is imetelstat. Not newsworthy.
07 Sep 2016, 04:22 PM Report Abuse Reply 2 Like

fishermangents
Comments (186) |+ Follow |Send Message
Which other drug do you mean? Imetelstat was on the agenda.
07 Sep 2016, 04:51 PM Report Abuse Reply 0 Like

Curiosity Killed The Cat , Contributor
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I just read the filing and Street_fighter is correct. The ODD filing is another drug that treats myelofibrosis and the filing references imetelstat as currently being the only drug designated for that condition in the EU. There have been other drugs in the past granted EU ODD in myelofibrosis but all have apparently lapsed or were eventually not approved for myelofibrosis (pomalidomide, fedratinib, momelotinib) or were withdrawn (ruxolitinib). So the question remains what is this new drug? My guess would be glasdegib – Pfizer’s SMO inhibitor currently in Phase 2 (NCT02226172) in Myelofibrosis patients resistant to ruxolitinib. Any ideas?

[cheng_ho]

Thanks Scott. Obviously I don't know what the EMA is talking about, because they don't release their meeting minutes for over a month (wonder how many times they get rewritten over that time...) I was just passing on the SA discussion.

[biopearl]

Cheng, my apologies, I see that you were just passing on info which as yet we are not sure is valid or not. Didn't mean to be snippy. bp