ImetelChat

Yes, I agree, this should be one of, if not the last, piece for final approval.

COMP doesn't just meet when a drug has a positive CHMP opinion though. Their agenda includes drugs at all stages of development and approval. See my previous comments about their agenda for the 21 Jan meeting in other ...

The agenda from the 21-23 Jan COMP meeting is back up after being off line for some reason. See link below. Looking forward to hearing how it went.

https://www.ema.europa.eu/en/documents/agenda/agenda-comp-meeting-21-23-january-2025_en.pdf

4. Review of orphan designation for orphan medicinal ...

We've all seen that BP.

Someone said there is a delay. I said no, it's just going through the process. And as I mentioned, there is a footnote to the positive opinion it says COMP is looking at the orphan designation. I then provided the details of the 21-22 Jan COMP meeting showing a oral ...

KMall

As I said on another thread:

There was a COMP meeting on 21 Jan in which Rytelo's approval as an Orphan designated product was up for adoption.

From the agenda, the title of the section is:
4. Review of orphan designation for orphan Medicinal products at time of initial marketing ...

BP, I've read that many times since it was out.

Just for clarity, which bit are you highlighting?!

Is it the footnote that they are reviewing the orphan designation? That's also what I am pointing out with the COMP page, that it is currently saying "Other Procedure" whatever that means.

And that ...

I didn't see someone else picked this up.

Note the link to the agenda doesn't work now.

Yes comp and chmp are different. Comp were to review the orphan designation in the Jan 21 meeting. See my comment above about an Oral explanation.

The COMP website was updated 7 Feb to "Other Procedure".

https://ec.europa.eu/health/documents/c ... /o2305.htm

The link above says Rytelo has "other procedure" noted at end of Jan. Any ideas?

The agenda of the 20-22 COMP meeting is no longer on the website.

There isn't a delay imo. It's just process. They have until 67 days, and authorisation for other drugs are coming through in dribs and drabs.

There was a COMP meeting on 21 Jan in which Rytelo's approval as an Orphan designated product was up for adoption.

From the agenda, the title of the section ...

Well done everyone! This has been a long road!

https://www.fda.gov/drugs/developmentap ... efault.htm

Investigational New Drug (IND) Application