Replies to post #511143 on Anavex Life Sciences Corp (AVXL)

[Bourbon_on_my_cornflakes]

If you are right, you could restore my faith in bureaucrats

There have been two unusual procedural twists in the blarcamesine MAA: First, the CHMP's four weeks heads up on an expected negative CHMP vote that was combined with an invitation to submit biomarker data; and, second, the committee's acceptance of a third party intervention before the initial committee vote (rather than during the re-exam).

Both of these actions demonstrate the CHMP committee's clear desire to be further educated on the science underlying this novel drug.
... it appears to me that the CHMP committee is showing signs of an appetite to do the harder work of approving a potentially groundbreaking drug

[Steady_T]

I must have missed the invitation to submit biomarker data prior to the reexamination.

Looks to me like Anavex won't be providing that biomarker data until the reexamination.

Here is what the Anavex PR said. Bolding is mine.

The Company was informed by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) of a negative trend vote on the Marketing Authorisation Application (MAA) for blarcamesine following its CHMP oral explanation. The CHMP is expected to adopt a formal opinion on the MAA at its December meeting. The Company intends to request a re-examination of the CHMP opinion upon its formal adoption, including providing relevant biomarker data, based on feedback and continued guidance from the CHMP, EMA and the Alzheimer’s disease community. The EMA procedures adopted by the CHMP allow an applicant to request re-examination of its decision, which would be undertaken by a different set of reviewers that conduct a new examination, independent from the first opinion.

[Investor2014]

You see light at the end of a tunnel.

[Boopka]

Boi, I concur with your views. However, does this mean that ALL supporting evidence from Anavex and third parties will be evaluated for the Friday vote? Missling clearly stated they expect to receive a negative vote so I am wondering if the committee will need time to evaluate. Hence an April decision.
If the committee does consider the data Anavex and third parties sent and they still receive a negative vote, what additional information/data does Anavex have to sway the EMA during the reexamination? Would seem futile at this point?

[abew4me]

I will add another (very important!) point to your theme...

Don't think for a minute that the EMA isn't aware that the FDA is now accepting one pivotal trial to qualify for approval. The question is, will the EMA accept Anavex's P2b/3 trial as a pivotal trial?

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FDA shifts to one-trial approvals, setting new standard for drug reviews

The news: Pharma and biotech companies will soon be able to seek drug approvals with just one clinical trial instead of the standard two under upcoming policy changes from FDA chief Marty Makary, per STAT.

The new one pivotal trial requirement that Makary deemed “more practical” is meant to help speed up reviews and approvals.

https://www.emarketer.com/content/fda-shifts-one-trial-approvals--setting-new-standard-drug-reviews