Can blind faith be unblinded as we muse over these MIssling pronouncements.
One would think that with the very high rate of turnover from the original trial into the extention study (guided over 90%) that we would have more than 78 of the early Alzheimer's patients (at last count) continuing and benefitting from treatment. I would be "very excited" if it were double that population.
The Therapeutic Candidates (pipeline) on the website reads like a major pharmaceutical company. This plus the mystery indication is another muse.
I would be very excited if we had one or two P3 trials up and running (PD + Fragile X). Consider this another muse as Anavex has been "rounding the corner " for more than two years of nothing here...
This CEO, unless there is a master grand plan that he and Kellmeyer are working on, has put the company and its science in a very vulnerable place. It felt like at the beginning of '25 that we would be applying to many other (actually named) countries by this time!
Now all we know is this from the horses mouth for the entire companies future:
We believe that the initiated dialogue reinforced our shared commitment to addressing the urgent unmet need in Alzheimer’s disease,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “Our team is committed to continue working in partnership with regulatory bodies in order to advance science and potentially new oral treatment options for patients and their families.”
Now, we can possibly "expect" or God help us "believe" as per Misslings latest words that "initiated dialog and reinforced shared commitment" can turn into an upcoming PR of CHMP re-examination acceptance and a positive opinion come April. If this path happens, then MIssling can actually use the word decision (instead of feedback) while anticipating the final EMA word. Inbetween that, I guess they can apply for approval with all current data elsewhere (that would surely be a sign of confidence), shop around at JP Morgan or start a new P#3 trial.
Happy Holidays and good health to all here and see you in '26...
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