EMA discussion

[sandshark]

With the recent comments by Chip during the Q2 conference regarding EU approval:

"We believe this could represent a favorable commercial positioning since currently most patients with non-del(5q) lower risk MDS generally proceed from treatment with ESAs to treatment with either lenalidomide or HMAs. In addition, imetelstat could offer much needed alternative for physicians and patients especially in the European Union where HMAs and lenalidomide are not approved for lower risk MDS"

basically saying that the EMA may have no other choice but to approve Imetelstat (for MF as well?) since they don't have many other options approved.

I was wondering what the opinions were here on the forum about possible EMA moves and whether we can maybe expect them sooner than a FDA move.

Some other things to take into regard:

- Janssen located in Europe.
- Guy on LinkedIn employed by Jansen being part of the 'Imetelstat launch team', located in Europe.
https://dk.linkedin.com/in/lasse-nielsen-ba760a69
- EMA removed the Orphan Status Designation and Orphan Opinion for IMbark from its files on July 30, 2018.

[sandshark]

Last EMA action referring to the posts from Anne S on Yahoo finance:

https://finance.yahoo.com/quote/GERN/co ... cc6&bcmt=1

click name and scroll down

[BumbleBean222]

Sandshark,

It appears that the orphan status for imetelstat still stands. Unless I am not looking in the correct location on the EMA site? could you post a link to correct me, if in fact this isn't correct. Thanks !

http://www.ema.europa.eu/ema/index.jsp? ... 058009a3dc

[sandshark]

Sandshark,

It appears that the orphan status for imetelstat still stands. Unless I am not looking in the correct location on the EMA site? could you post a link to correct me, if in fact this isn't correct. Thanks !

http://www.ema.europa.eu/ema/index.jsp? ... 058009a3dc

What I read was that a few of their pages were updated, which could indicate they received the primary analysis.

Indeed no panic, orphan drug designation status has certainly not been removed.

It's more to the positive side:

"Something Maybe Up with Orphan Status MF. EMA has removed the Public summary of opinion on orphan designation Imetelstat and Human medicines EU/3/15/1593 from its database for MF. Some have commented that this is similar to what was done with Jakafi. The EMA had a Outcome Positive on the MF CT."

"What EMA deleted from its files:

1. Public summary of opinion on orphan designation Imetelstat

2. Human medicine EMEA 001910-PIP01-15

These was EMA granting Orphan status for Imetelstat and their Opinion which was favourable towards Imetelstat for MF."

"When EMA made those modifications to the Orphan Status of MF, July 30, 2018. in their files, the EMA has essentially received the Primary Analysis of IMbark."

"EMA should Authorize Imetelstat for PMF"

[cheng_ho]

Sand, "Anne" has been notifying us of imminent EMA approval for years now

...and maybe someday she'll be right. But right now we don't even know if Janssen has applied for anything.