Here is an article that may interest a few hereEU committee...

Here is an article that may interest a few here

EU committee confirms negative opinion for Amylyx ALS drug, rejecting company appealMax GelmanSenior EditorThe European Medicines Agency rejected on Friday an appeal from Amylyx Pharmaceuticals to reconsider a negative review opinion for its ALS drug Relyvrio, further dimming hopes of an approval in the EU.
Regulators on the EMA’s CHMP committee said that their “concerns were not resolved” after initially handing down a negative opinion in June. A final decision will be made by the European Commission, which typically follows the advice of the EMA and CHMP, before the end of the year.
In an emailed statement to Endpoints News, Amylyx co-CEOs Joshua Cohen and Justin Klee said they will continue “working with urgency toward providing timely, broad, and sustainable access to AMX0035 for eligible people living with ALS who may benefit.”
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Amylyx has faced a rockier road to approval in Europe than elsewhere. Though it secured a green light in the US despite an atypical path — featuring two adcomms, high patient and advocate enthusiasm and a public FDA reversal — an EU thumbs-up continues to prove elusive.
The EMA’s June review initially said the drug did not “convincingly” slow the worsening of ALS in a clinical trial. Survival data were also unreliable, “given the way the data were collected and analyzed,” the committee added at the time.
That opinion prompted Amylyx’s appeal for conditional approval.The company is in the midst of running a Phase III trial that it hopes can bolster its case. Topline data are expected in mid-2024, and if they read out positively, Amylyx will “seek approval in the EU as quickly as possible,” a spokesperson wrote in an email.Canada also approved the drug “with conditions” last year under the name Albrioza, which is the proposed branding in Europe.
AUTHORMax Gelman