Replies to post #63764 on Anavex Life Sciences Corp (AVXL)

[JB3729]

The detailed data AVXL is now compiling could prompt a BTD application -

Ideally, a Breakthrough Therapy designation request should be received by FDA no later than the end-of-phase-2 meetings if any of the features of the designation are to be obtained. Because the primary intent of Breakthrough Therapy designation is to develop evidence needed to support approval as efficiently as possible, FDA does not anticipate that Breakthrough Therapy designation requests will be made after the submission of an original BLA or NDA or a supplement. FDA will respond to Breakthrough Therapy designation requests within sixty days of receipt of the request.

http://www.fda.gov/ForPatients/Approvals/Fast/ucm405397.htm


Renoit7 Thursday, 11/26/15 03:10:05 PM
Re: Amatuer17 post# 40465
Post # of 63764

I contacted them regarding an application for Breakthrough Therapy Designation and the response I received this morning was:

"The company intends to pursue Breakthrough Therapy Designation and material information will be shared with all investors according to Regulation FD"

My question was if they were planning on applying for BTD and if they would be announcing their application or if they'd wait until the received a response from the FDA to disclose. So I never really got my full question answered, and I'm not even sure what the 'FD' is referring to. Anyone with an experience where BTD was given and if the company announced their application or not?

[JB3729]

AVXL will seek BTD. We just don't know when.

Closetinvestor stated this -

The results are promising but the phase 2/3 data must be good in order for the FDA to grant breakthrough designation.

Which is wrong.

[McMagyar]

The NUMBERS are NOT GREAT ENOUGH, n-=32 is TOO SMALL.
"We don't have enough data, playing piano not enough"
blah, blah, blah..
Wrong, Wrongk, Wrongker.

The FDA just designated a Drug Breakthrough Designation after
PHASE 1. IF the Science is PROVED as a BREAKTHROUGH ..Designation does NOT NEED to WAIT for PHASE 3..Says THE FDA..
Don't want to bore you but at 5 Weeks we had PK Confirmed..starting at 5 Mg of dosage..and at 5 weeks we had almost an 80% Curative Response-Succesful Treatment.as around 25 of 32 Patients averaged improved response(not stable-but Curative-getting better)

The FDA just designated the same Eli Lilly Drug Abemacyclib "Breakthrough" after ONLY a TOTAL 13 PATIENTS showed SOME Curative Effect..Partial REMISSION(did not appear per the news any Full Remissions). Other Patients showed NO PROGRESSION-which in Cancer(like ALzheimers) is considered Succesful Treatment.This total along with Regression Population was
The investigational anticancer therapeutic abemaciclib, which targets CDK4 and CDK6, showed durable clinical activity when given as continuous single-agent therapy to patients with a variety of cancer types, including breast cancer, non-small cell lung cancer (NSCLC), glioblastoma, and melanoma, according to results from a phase I clinical trial
Radiographic responses were observed for some patients with breast cancer, NSCLC, and melanoma. Among the 36 patients with hormone receptor-positive breast cancer, 11 had a partial response, with four of the 11 responders having continued prior endocrine therapy, and an additional 18 patients had stable disease. Among the 68 patients with NSCLC, two had a partial response and 31 had stable disease; one patient who had a partial response and 12 who had stable disease were known to have KRAS-mutant NSCLC. Among the 26 patients with melanoma, one had a partial response and six had stable disease. Three of the 17 patients with glioblastoma had stable disease, with two of them continuing to receive treatment without disease progression for 19 and 23 cycles, respectively..

Total of 147 Patients listed above: Respnse Rate
14 out of 147 had PARTIAL RESPONSE.= 9.5%
45 out of 147 had STABEL DISEASE = 30%

Overall Response Rate of 40% in PHASE 1 = BREAKTHROUGH DESIGNATION

So by the numbers Anavex has at LEAST 11 Patients showing CURATIVE Response-Higher Scores on ADCS-ADL. If YOU go by 5 Weeks data than A2-73 shows Curative Effect on almost TWICE as MANY PATIENTS as the Abemacyclib that just GOT FDA Breakthrough Designation. AND if you go by a Percentage of Population responding VS straight numbers..well A2-73 Respnse rate at 5 Weeks and interim 12 weeks on a PERCENTAGE BASIS is near 80% or TWICE the response rate fo the Eli Lilly Drug that just GOT BREAKTHROUGH DESIGNATION. So ..Anavex is going to Breakthrough because teh numbers don't lie..