Replies to post #457795 on Anavex Life Sciences Corp (AVXL)

[FooBarAndGrill]

The definition, from the horse's mouth, could use a little work IMO.

One of the two members of a committee or working party who leads the evaluation of an application.

https://www.ema.europa.eu/en/glossary/rapporteur

[makemydaze]

I wondered the same thing earlier. Per the link that follows: "For each application for a new medicine, two committee members - known as rapporteur and co-rapporteur - from different countries are appointed to lead the assessment (for generics only one rapporteur is appointed). They are appointed according to objective criteria to make best use of the available expertise in the EU.

The role of the rapporteur and co-rapporteur is to conduct the scientific evaluation of the medicine independently from each other. They each form an assessment team with assessors from their national agency and sometimes from other national agencies.

In their assessment reports, each team summarises the data from the application, presents its judgments of the medicine’s effects and its views on any uncertainties and limitations of the data. They also identify questions that will have to be answered by the applicant. The two separate assessments take into account regulatory requirements, relevant scientific guidelines and experience in the evaluation of similar medicines.

In addition to the rapporteur and co-rapporteur, the CHMP also appoints one or more peer reviewers from amongst the CHMP members. Their role is to look at the way the two assessments are performed and ensure that the scientific argumentation is sound, clear and robust."

https://www.ema.europa.eu/en/about-us/what-we-do/authorisation-medicines/how-ema-evaluates-medicines-human-use

I liked this part also:

"Did you know..?

In some cases, for example when a medicine is intended to treat a life-threatening disease for which there is no satisfactory treatment or if the disease targeted is very rare, EMA can recommend marketing authorisation on the basis of less complete or limited evidence on the medicine, provided that further data are provided at a later stage.

As for all marketing authorisations, it must still be demonstrated that the benefits of the medicine outweigh the risks."