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tradeherpete

01/26/21 12:27 AM

#294229 RE: georgejjl #294222

Thanks george,

Looks like the Rett Avatar trial is due to end in less than a week.

Avatar was a great movie. I liked the opening and closing scenes the most. They show the same thing, someone opening their eyes.

What are the chances the FDA looks at Biogen’s data and makes a decision to allow them to pursue another P-3 trial?

Wouldn’t that would be a positive for them and offer them a chance to give their drug a fair showing with a clean slate?

It could also wipe the stains from the Billy Dunn controversy clean.

The FDA could listen to the Alzheimer’s Association’s requests and refer them to options that more directly give Alzheimer’s patients real hope.

And in a short month the Anavex Rett study could be completed.

ANAVEX2-73 Study in Patients With Rett Syndrome (AVATAR)

Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : February 28, 2021



https://clinicaltrials.gov/ct2/show/NCT03941444

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ExtremelyBullishZig

01/26/21 6:26 AM

#294232 RE: georgejjl #294222

Oops...still recruiting...

Facts.
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nidan7500

01/26/21 8:54 AM

#294248 RE: georgejjl #294222

This group of patients ( AVATAR) patients 18 years and older with RTT) may present a spectrum of change unlike any other (before/after). What an amazing moment they and their families may (hopefully)experience. IDNK who chose this grouping or why but can see a vast spectrum of life changing CNS disease drama. Bless them and best wishes it goes well for everyone.

Wonder if Dr. H. will comment.

ANAVEX2-73-RS-002 is a Phase 2, double-blind, randomized, placebo-controlled dose escalation safety, tolerability and efficacy study in patients 18 years and older with RTT using endpoints including multiple clinical and exploratory molecular and biochemical measures.



ANAVEX2-73 Study in Patients With Rett Syndrome (AVATAR)

Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : February 28, 2021



https://clinicaltrials.gov/ct2/show/NCT03941444

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TempePhil

01/26/21 12:39 PM

#294290 RE: georgejjl #294222

Some items regarding Avatar:

ANAVEX2-73 Study in Patients With Rett Syndrome (AVATAR)

Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : February 28, 2021


Expect Avatar completion dates to be accurate, as these were the only Avatar record items updated at the last update (end of November).

OK, if given that completion dates are accurate, then what does that mean in terms of schedule?

It was curious that the Avatar enrollment status was not updated on the Dec 28 CC, as this trial was the one next up to have full enrollment and complete. Yet the AD trial enrollment, was updated, and it will not complete for a year. Why?

Working back from Jan31 Primary Completion (last patient, last data collected) 7 weeks, would put the last patient enrolled/accepted at Dec.7...12 days after the record update. Interesting..12 days schedule 'padding' or just coincidence?

On Dec28, the enrollment should have been complete, for trial Primary completion to end Jan31.

Dr.M just keeping the cards very close to his vest?

Almost end of January and no word of FDA meeting date. Is Dr.M waiting for the Avatar high dose data, so he can have both high and low for the meeting?

Ana estimates 33 patient results will take all of February.
March+ could be very interesting! We will be there soon!