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Re: Gravedigger1 post# 506816

Tuesday, 11/11/2025 9:27:12 AM

Tuesday, November 11, 2025 9:27:12 AM

Post# of 517639
Missling also responded to "why the EU submission" and replied because the trials were run there (AUS & CA also). What are the chances that the EMA fielded requests from outside the trial participants for the medication. Could word of mouth on efficacy spread around through loved ones (#friendsandfamily). Hey anything is possible. Godspeed to the team on this meeting in progress with even more convincing data of late. So this tiny baby bio consisting of 42 employees is at the doorstep at greatness. Perhaps the CHMP has concerns more about execution of an approval. Sandra certainly isn't going to count scripts. I would feel that all must be clearly defined, manufacturing, distribution, (reimbursement structure), patient and medical professional support/education resource portals, etc, etc, etc...
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