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My Fidelity charts are indicating the "golden cross" will occur tomorrow using the simple 50-day and 200-day moving averages.
Perhaps we get a boost from investors looking a technical indicators?
Why do people keep asking this? The FDA IS NOT ANNOUNCING ANY TRIALS. They will be announcing 5 CNS guidances. And what was once said to occur by year end could be delayed for any number of possible reasons.
I wonder if the excerpt below means the trial announcements will be on hold until after this March 20th public meeting.
Novel Clinical Trial Designs
As technology improves, so does FDA’s ability to explore novel trial designs that better fit the
needs of researchers and patients. FDA is committed to supporting the use of novel trial designs,
modeling, and simulations in drug development and review, to do things like support evidence of
effectiveness, optimize dosing, and evaluate adverse event mechanisms.
Building on work that was already underway at the Agency, the Cures Act specifically calls on
FDA to assist sponsors in incorporating complex adaptive and other novel trial designs into
proposed clinical protocols and applications for new drugs and biological products to facilitate
more efficient product development. To do this, FDA is actively planning a public meeting for
March 20, 2018. The Agency plans to issue guidance on, among other things, how to use such
novel trial designs, how they can help to satisfy the substantial evidence standard, and what are
recommended analysis methodologies.
Overall sentiment is strong with institutional ownership up to 23.3% Blackrock and others increased their ownership as well.
I've been wondering the same thing. I thought by the time a pivotal trial begins there is always a name given?
I agree. I have seen ALNY move over $7B market cap with the promise of a drug "platform". I imagine AVXL would have even greater future cash flow potential given all the indications that would be viewed within reach after Rett's approval.
For the technically minded folks here, should I be concerned the 50 day SMA is approaching a death cross with the 200 day SMA? At the recent rate of decline it will cross in about 10 trading days.
I have not heard Dr. Missling use the term "pivotal" yet in relation to the upcoming AD trial. It was either in a recent presentation or radio interview I heard him say that the FDA might require additional testing after the upcoming phase 2/3 trial.
I used to be invested in $GERN. I just don't have a good feel for whether Janssen will exercise option to continue collaboration.
I went back and looked at the AVXL patent issued 11/10/2015 (application 14/205637) and it took them 67 days to pay the fee after the electronic review was logged. Consequently, it did take another month after payment until this patent was officially issued, so it still might be 1-2 months until we see a PR. I can't imagine them releasing a PR for the payment. They will likely wait for the issuance.
Does anyone know that if we use some genetic marker(s) as a criteria for inclusion in the P3 trial, will this limit the eventual approval to this same limited AZ population? I'm
Just trying to understand if this genetic approach in someway might reduce future value calculations.
Today's chart wreaks of manipulation. Someone does not want AVXL to break past $6.08 and run, with it bouncing between $6.07 and $6.08 in a fairly long cyclical pattern for a stock of this volatility.
I absolutely believe Missling that all 3 trials will start in 2017. Whenever he gives presentations with catalysts listed to occur in a certain year he delivers.
Not saying so in the filing is simply smart to avoid any frivolous lawsuit liability should something unforeseen cause a delay.
In my mind starting AZ trial in 2017 could mean that only recruitment starts before the end of the year.
If anything this filing reveals that, as we suspected, the Retts trial will be the first to start with possible readout before the end of 2017.
There has been no delays. Dr. Missling layed out the catalysts below for this year. There was no promise as to what quarter or month the trials would begin. I suspect the catalysts below will be executed in near chronological order, with 18 month trial update and PK/PD data release occurring in the summer and perhaps all three trials beginning in Q4.
Catalysts in 2017
??
X Granted Orphan Drug Designations for the following indications: Rett Syndrome, Infantile spams and Frontotemporal dementia
X Phase 2a – Report PART B 57 week data at CTAD scientific meeting
Phase 2a – Updates on 104 week extension Alzheimer’s study
Phase 2a – Report PK/PD data
Initiate Phase 2 clinical trial in Rett Syndrome (12 week, randomized, double-blind, placebo controlled)
Initiate Phase 2 clinical trial in Parkinson’s (12 week, randomized, double-blind, placebo controlled)
Initiate Phase 2/3 clinical trial in Alzheimer’s (6/12 month, randomized, double-blind, placebo controlled)
Potential for clinical read-out by end 2017 / early 2018 Complement current pipeline through in-licensing – ongoing
I had to dig around a bit to find the notice of allowance being the first time I have visited this site. I also found the transaction history below. Looks like AVXL reviewed the electronically transmitted notice of allowance yesterday, so I suppose it is still possible a PR is coming this week.
Transaction History
Date Transaction Description
05-09-2017 Electronic Review
05-05-2017 Email Notification
05-05-2017 Mail Notice of Allowance
05-02-2017 Notice of Allowance Data Verification Completed
04-24-2017 Interview Summary - Applicant Initiated - Telephonic
04-25-2017 Reasons for Allowance
04-25-2017 Examiner's Amendment Communication
04-25-2017 After Final Consideration Program Additional Consideration and/or updated search
04-19-2017 Date Forwarded to Examiner
04-17-2017 Response after Final Action
04-17-2017 PILOT- Request for After Final Consideration Program
04-18-2017 Mail Interview Summary - Applicant Initiated - Telephonic
04-13-2017 Interview Summary - Applicant Initiated - Telephonic
I agree. My recollection is that similar catalyst slides in that past have generally played out chronologically to how they are listed. In addition, Dr. M. always delivers once he lists a specific year for a particular catalyst.
If you read the most recent presentation before conference you should not have had expectations of seeing 15 week results.
Catalysts in 2017 (slide #38 of March 2017 Corporate Presentation)
- Granted Orphan Drug Designations for the following indications: Rett Syndrome, Infantile spams and Frontotemporal dementia (CHECKED)
- Phase 2a – Report PART B 57 week data at CTAD scientific meeting (CHECKED)
- Phase 2a – Updates on 104 week extension Alzheimer’s study
- Phase 2a – Report PK/PD data
- Initiate Phase 2 clinical trial in Rett Syndrome (12 week, randomized, double-blind, placebo controlled)
- Initiate Phase 2 clinical trial in Parkinson’s (12 week, randomized, double-blind, placebo controlled)
- Initiate Phase 2/3 clinical trial in Alzheimer’s (6/12 month, randomized, double-blind, placebo controlled)
- Potential for clinical read-out by end 2017 / early 2018
Holy cow! Did Misling just slip and let out of the bag positive results from the Biogen testing relative to MS?
I received the same call this morning regarding the proxy. I happily voted yes to all proposed items over the phone.
I have heard many of those long-term care insurance policies have caps.
My approach is to make millions with AVXL so I (or my family) can afford to hire in-home nurses when I get to the nursing home point. I don't think Ronald Reagan ever was in a Nursing home.
Did he say there were no more questions or that they ran out of time? It sounded like they let the first guy go on and on with follow-up questions but only took questions from 2 callers.
A quick question for those on this board who more experienced in biotech investing:
Is it unusual for a small biotech like AVXL to not conduct conference calls at their quarterly shareholder meetings?
I invest in a couple other biotechs with a market cap larger than AVXL but less than $1B and find these conference calls very informative. I think they help add a layer of tranparency by fielding open questions from analysts and shareholders, rather than strictly releasing information in a planned and scripted manner.
My concern with transparency is why our CEO cannot conduct conference calls at the quarterly meetings. I invest in other small biotechs who do conduct conference calls and they can be very informative for investors.