Good post, boi.
Getting the EMA to accept our data for pre-submission allows Anavex to complete the full submission when our OLE is finished. The beauty of this scenario is the timing because every company must go through the pre-submission process.
By submitting our data for pre-submission now, allows the EMA to go through their normal evaluation process...which takes 6 - 7 months. By the time they're finished evaluating everything, we will have our OLE data ready to be submitted for full approval.
THAT is good management.
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":...The Marketing Authorisation would allow direct market access throughout the European Union for oral blarcamesine for the treatment of Alzheimer’s disease. There are an estimated 7 million people in Europe with Alzheimer’s disease, a number expected to double by 2030, according to the European Brain Council...."
"...We have met the European Agency several times in meetings and we have shared the data which is not yet published, which is the published date of -- the planned published communication of the full data of the Alzheimer Phase 2b/3 study. And we were from this meeting recommended to proceed with this application, full approval application. And that's what we proceeded with last week accordingly...."
"...Full data from the blarcamesine in Alzheimer’s disease Phase 2b/3 randomized clinical trial will be published in an upcoming peer-reviewed journal..."
