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IanFromSI

06/19/22 10:12 AM

#3131 RE: north40000 #3130

Yes, The company's PR and the Seeking Alpha coverage are in the Ihub news coverage shown in this thread.

While disappointing, it's almost par for the course.

There's still a significant unmet medical need where the alternative (off label use of anti-psychotics) frequently causing irreversible harm turning patients into near vegetables and completely removing any quality of life. Sort of a Lose-Lose-Lose for the doctors, patients and families.

Nuplazid helps about a third of patients substantially improving quality of life for that subset. For that third, the Psychosis and MDD is successfully treated. - almost a miracle drug for that subset.

For PDP prospective patients, ACAD gave the first 30 days Nuplazid supply free allowing the doctors and patients to determine if it was an effective tx for each pt.

Hopefully, for the patients and their families, a similar approach would allow the FDA to conditionally approve - substantially improving quality of life, but only for about a 1/3 of patients.
After the BIIB fiasco, where the FDA approved a drug that just didn't work at all for any patient (AD), they're probably a bit gunshy re not taking Adcom advice.

We'll find out in August.