Agreed. PCGuy did a great job explaining why those companies were rejected by the EMA and/or CHMP.
But that begs the question: Why were they accepted by the application committee in the first place? Aren't they supposed to see the deficiency in their studies before they submit them to CHMP to be considered?
The fact that they were accepted for consideration cheapens the process and makes me feel that AVXL had an easier screening than I thought...and that reduces my confidence for approval.
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Monday, November 10, 2025 10:48:15 PM (DD by PCguy)
Pridopidine is a Sigma 1 agonist. It missed both primary endpoints for HD, noting improvement in cognition. [How in the world did they get passed the app committee?]
Resminostat, the benefits didn't outweigh the side effects. Trial design did not demonstrate how long patients would benefit from the drug. [Sheesh!!!]
Atropine Sulfate FGK- the effectiveness had not been sufficiently demonstrated. [Stupid!!!]
Troriluzole - the main study did not show that Dazluma was more effective than placebo for the treatment of spinocerebellar ataxia. [You've got to be kidding?!!!]
Rechon- no conclusion could be drawn on whether Insulin Human Rechon behaves in the body in the same way as the reference medicine Humulin Regular.
Teriparatide Ascend - the study did not allow accurate measurements of the active substance in the body.
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