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Well, what if Biogen wants to do a combo with Tysabri? Anavex does Anavex Plus on its own, lots of possibilities.
Distribution deals..
Ok. Don't know much about them.
Distribution deals seems messy to me.
Is that a common or regular occurrence; for a company to buy another company's compound for just one indication while leaving the other indications on the table for the company (Anavex) to explore?
I don't see how our compound could be sold for only one indication (MS) while the other indi's (Alz, PD, RS) continue on their own path. It's all or nothing in my mind. Anyone else see a path forward for Biogen to lock up MS alone?
IMO - they should restore the old site and do the work behind the scenes.
They fixed the header and now the pubs page works, but all they did was throw some lipstick on this P. When you go to the events page, it would be nice if the webcast can been linked directly from that page. The only way you can see it is if you go to the home page and scroll below the header. Also, please get an updated "Message from the CEO" The one they have is from 2012, looks like a website lacking regular maintenance.
Somebody is confident. 5000 shares bought AH taking the pps to $4.88
I like your eq value, "$50.00 pps" but how exactly are you calculating that?
If Biogen announces a partnership with Anavex and makes funding available to run a study for MS using our compound, what do you think that would do to the pps? Anyone can chime in, TIA.
You say Noble, I say Nobel...I do tend to get ahead of myself sometimes. Although Dr.M clearly states they are "Now working with Biogen for MS", and putting the Biogen name on a slide confirms it's not a "Slip" of the tongue, it should be noted he did not repeat anything about MS in the upcoming catalysts. I believe that's the hidden catalyst that can't be announced until Biogen steps forward with a deal and announcement of their own. Any Day Now. IMO
If you watch the Nobel presentation at 7:26, slide 14 shows Biogen named under the funding heading of our pipeline for study in MS. Bingo! Go AVXL...Dr.M, You da Man!
http://noble.mediasite.com/mediasite/Play/2451c4d03e624780a689acb83b9ddbe81d
Are Shorts finally covering or are these new investors just enlightened on how strong our pipeline is?
When did Macfarlane say some patients switched to mono?
I don't think we disagree, just offering a alternate hypothesis:
a longer time doing the same thing that is not working to begin with will almost 100% of the time continue to not work. I believe it is the definition of insanity.
We have Monotherapy which has obviously stopped and reversed Alzheirms by creating Homeostasis. Affinity to logic.
Thank you Sokol, Xena, and all the others debating this thread regarding the disclosure of trial dosage changes. Your points are well taken; my point is we should not claim something as fact when it is speculation. We will know how they did it when all the data is analyzed. In the meantime, very grateful to be a part of/ witness to such science advances. Although it's too late for my parents, our future selves will be very blessed.
You seem to be making my point..
I see serious implications in pursuing the path of "switching" a patient to an unapproved mono-therapy -- "efficacy" has not been established! Anavex would, in my opinion, be foolish to "switch" patients to the mono-therapy and announce it to the world as you say.
Sokol, You are convinced that Mono is providing the better efficacy, but doubt that the company would disclose if such a switch is made. The question of the hour is; if the switch was made, why not disclose it? Speculating does not bolster confidence.
I would like to believe with faith as you do..
Personally, my confidence is not shaken because the data stands as extraordinary regardless of whether patients were changed or not.
OhSay, I'm with you. The lack of transparency is disturbing. So let's play the speculation game:
What if no changes were made to the mono vs. plus patients, and the results were heading up on an average as was presented? They switch from calling the sub group "Mono" to calling it "strong performers". What if the strong performers were not the "Mono" group? Would that be a reason to not disclose any trail changes? To what end...why not be specific?
I love your theories but am frustrated that we don't really know what changes they made during the trial. Are they all on Mono now? The question OhSay brought up has been on my mind for weeks; What is the advantage of not stating these details? Is there a downside to Anavex stating that all trial patients have been switched to mono? By not giving us these details they leave us to speculation and reduced confidence; not good for pps.
OhSay, I've been thinking the same thing..
Is there a reason that they could not explicitly state that patients were switched to monotherapy at the time of the last data release in December?
I agree with XenaLives. There are more people that have broken bones than AD. A quick google search says that 87% of the population will have a broken bone in their lifetime...avg. is two. Thus, any tests or surveys of AD patients would be inconclusive.
I usually don't want to see anyone get hurt, no matter how stupid they are. But; I agree, can't wait to see the SHORTS get squeezed out of this stock. The bottom line: there is far more upside than down, and with the results presented at CTAD, we have the confirmation that Anavex will pay off for investors and patients. The world is about to change!
I see what you are saying, as shown on the link you provided, but look at the last paragraph:
"If you do take advantage of the specific-shares method, make sure you receive a written confirmation from your broker or custodian acknowledging your selling instructions. You must determine the method that works best for you and stick with it."
That last part, "You must stick with it" is short in details, but true. Once you choose a method, you are required to use that method in the future. Thus, you cannot revert to FIFO after choosing specific shares.
Having said all that, using specific shares could be very useful. I need to look at the possible down side. Thanks for your enlightenment!
My point is, once you select a method and use that method in a tax year, subsequent years must be done the same way. If that's wrong, please enlighten me further, because that would be great.
Interesting trading concept, but unless the IRS is smoking what you're smoking, lol, I don't think they will allow it. If one could change their filing method from FIFO to most recent shares first, they could switch their method based on gains or losses. While it would be nice, it doesn't make sense; one could avoid taxes forever. I'd check with a tax expert before employing that theory.
Good Options Action today. Buying on the dip works there too. Even the $5 strike call for December has lots of room to run, currently under .25 premium. If the pps goes up tomorrow, those will be worth a min of .50+. Double your money in a day. Nice! The CC after hours will be more good news, IMO.
Hey Whiskey, you said
I'm going to be away from my computer for the entirety of the week and am trying to figure out if I should set a margin buy 1k at open and where I should set a specific sale point. Any opinions re: trading would be appreciated.
Thanks for your summary Tom and congrats on your 8000+4 posts. Too many variables all riding on what is presented tomorrow. Thankfully, we have the rest of the weekend to speculate about Monday. Doing it now before we see what is presented is a waste of time. Get some rest and enjoy the night off, you deserve it. Thanks again, good charting!
Biogen 24 month abstract : A: PRIME FROM DATA MONTH-24 ADUCANUMAB: OC31
CONTROLLED-PLACEBO, BLIND-DOUBLE, RANDOMIZED
PRODROMAL WITH PATIENTS IN STUDY 1B PHASE
,1 Viglietta Vissia. DISEASE S’ALZHEIMER MILD OR
Ahmed, Chen1 Tianle, Williams1 Leslie, Gorman1’O John
Enayetallah1
Chiao1 Ping,
Hock2 Christoph,
Nitsch2 M Roger,
,
Haeberlein1 Budd Samantha
,Biogen) 1 ((Sandrock1 Alfred,
and, Zurich-Schlieren, Neurimmune) 2; (USA, MA, Cambridge
(Switzerland, Zurich of University
amyloid-anti human a), BIIB037 (Aducanumab: Background
PRIME). AD (Disease s’Alzheimer early for treatment modifyingdisease
a as investigated being is, antibody monoclonal) Aß (beta
,tolerability, safety the evaluating study 1b Phase ongoing an is
patients in aducanumab of pharmacodynamics and, pharmacokinetics
month-24 report we, Here. weeks 54 at AD mild or prodromal with
months 12 first and period controlled placebo month-12 the from data
included Patients: Methods. period) LTE (extension term long the of
,controlled-placebo, blind-double, randomized, multicenter this in
,years 90-50 aged were) NCT01677572; PRIME (study dose multiple
tomography emission positron) 45 AV 18F (florbetapir positive a had
.AD mild or prodromal for criteria clinical met and, scan) PET(
received patients, phase controlled placebo, blind-double the During
a In. weeks 52 for weeks 4 every once placebo or aducanumab
fixed to randomized were patients, design group-parallel, staggered
E4 apolipoprotein by stratified) kg/mg 10-1 (aducanumab of doses
dose a included also study The). carrier-non/carrier (status) e4 ApoE(
titration the for data month-24; here reported not (cohort titration
LTE the in inclusion for eligible be To). available yet not are cohort
have must 56 Week at patients), years 3 to up of period a (period
or 11 received, study the of portion controlled-placebo the completed
an had and, doses consecutive 2 than more missed not, doses more
For. 52 Week at 10 >score) MMSE (Examination State Mental-Mini
10 or, 6, 3 aducanumab receive to assigned were patients all, LTE the
patients: follows as were LTE the in assignments dose Their. kg/mg
received phase blind-double the during placebo received had who
aducanumab of regimen titration a or kg/mg 3 aducanumab either
doses subsequent by followed kg/mg 3 of doses 2 (kg/mg 6 to 3
receive to randomized were who Patients. LTE the in) kg/mg 6 of
subsequently phase blind-double the during kg/mg 1 aducanumab
other All. LTE the in kg/mg 3 aducanumab receive to assigned were
reduced or assignment dose original their at continued phase blinddouble
the during kg/mg 10 or, 6, 3 aducanumab receiving patients
LTE the for endpoint primary The). continuers aducanumab (dose
adverse of incidence by measured as tolerability and safety was
the for endpoints Exploratory). SAEs (AEs serious)/AEs (events
PET amyloid using reduction Aß of measurement a included LTE
change and]) SUVR [ratio value uptake standard by assessed as(
Dementia Clinical the including, endpoints clinical in baseline from
mixed A. MMSE the and scale) SB-CDR (Boxes of Sum-Rating
analysis the for used was) MMRM (measures repeated for model
.MMSE and, SB-CDR, PET amyloid in baseline from change of
the within PRIME in dosed and randomized patients 165 Of: Results
completed 91 and LTE the in dosed were 117, cohorts dose-fixed
in decrease significant a, months 24 After. 24 Month at treatment
from patients those in observed was burden plaque amyloid brain
LTE the in treatment continuing groups kg/mg 6 and kg/mg 10 the
placebo from switched had who patients those with compared
:SUVR PET in baseline from change] error standard [mean adjusted(
6 and kg/mg 10 aducanumab with] 028.0 [284.0 -and] 031.0 [329.0-
001.0<P; switchers placebo for] 027.0 [162.0 -vs respectively, kg/mg
plaque amyloid brain in Decreases). Figure; respectively, 01.0<P and
aducanumab to switched patients among observed also were burden
continuer aducanumab the in patients, months 24 After. LTE the in
in decline clinical of slowing consistent demonstrated also groups
the), ARIA (abnormalities imaging related-amyloid For. LTE the
or placebo from switched who patients in cases ARIA of incidence
regimen titration the or kg/mg 3 aducanumab to kg/mg 1 aducanumab
blind-double the during observed that with consistent generally was
LTE the in observed were cases E-ARIA new No. study the of phase
:Conclusions. groups continuer aducanumab the in patients those in
the from aducanumab with treated were who patients, months 24 At
continued period LTE the through phase blind-double the of beginning
time and- dose a in burden plaque amyloid brain in decrease a show to
MMSE and SB-CDR. PET amyloid by measured as manner dependent
aducanumab from benefit sustained a suggest also months 24 over data
in ARIA of incidence The. treatment continued who patients those for
that with consistent was treatment aducanumab to switching patients
cases new no and, study the of phase blind-double the during observed
continuer aducanumab the in patients in observed were E-ARIA of
.56-50:537;2016 Nature. al et J Sevigny. 1: Reference. groups
MO
The abstracts page is finally posted. Here is the Biogen abstract, will copy AVXL next :N DOSING TITRATION ADUCANUMAB: OC21
A, PRIME FROM ANALYSIS INTERIM MONTH-12
CONTROLLED-PLACEBO, BLIND-DOUBLE, RANDOMIZED
PRODROMAL WITH PATIENTS IN STUDY 1B PHASE
,1 Viglietta Vissia. DISEASE S’ALZHEIMER MILD OR
, 1 Chen Tianle , 1 Williams Leslie , 1 Gorman’O John
,Hock2 Christoph, Chiao1 Ping, Enayetallah1 Ahmed
Nitsch2 M Roger
Haeberlein1 Budd Samantha,
Sandrock1 Alfred,
(Switzerland, Zurich of University and, ZurichSchlieren,
Neurimmune) 2; (USA, MA, Cambridge, Biogen) 1((
amyloid-anti human a), BIIB037 (Aducanumab: Background
PRIME). AD (Disease s’Alzheimer early for treatment modifyingdisease
a as investigated being is, antibody monoclonal) Aß (beta
,tolerability, safety the evaluating study 1b Phase ongoing an is
in aducanumab of pharmacodynamics and, pharmacokinetics
that found analysis interim An. AD mild or prodromal with patients
(E-ARIA (edema vasogenic-abnormalities imaging related amyloid
and dose were these; findings tolerability and safety main the were
that hypothesized is It 1.dependent) e4 ApoE (E4 apolipoprotein
regimen titration a in administered be can aducanumab of doses higher
ARIA of extent same the incurring without carriers e4 ApoE in
an included, therefore, PRIME. regimen dose-fixed a with observed
.regimens dosing fixed to addition in regimen titration aducanumab
,randomized, multicenter this in included Patients: Methods
;PRIME (study dose-multiple, controlled-placebo, blind-double
florbetapir positive a had, years 90-50 aged were) NCT01677572
met and, scan) PET (tomography emission positron) 45-AV-18F(
,blind-double the During. AD mild or prodromal for criteria clinical
placebo or aducanumab received patients, phase controlled-placebo
group-parallel, staggered a In. weeks 52 for weeks 4 every once
or aducanumab of doses fixed to randomized were patients, design
status e4 ApoE by stratified) placebo vs active 1:3 of ratio (placebo
dose-fixed the into enrollment patient After). carrier-non/carrier(
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aducanumab of doses titrated either received who carriers e4 ApoE of
the, doses titrated receiving those For. placebo or) kg/mg 10 to up(
the for kg/mg 3, doses 2 first the for kg/mg 1 was regimen dosing
.thereafter kg/mg 10 and, doses 5 next the for kg/mg 6, doses 4 next
3.5 was arm titration the in dose expected average the, 52 Week By
cohorts dose-fixed the from data interim month-12 While. kg/mg
for data interim the here report we 1,previously reported been have
reduction Aß regarding regimens dose titration as well as fixed the
Dementia Clinical (endpoints clinical exploratory, PET amyloid using
Examination State Mental-Mini and] SB-CDR [Boxes of Sum-Rating
.ongoing is PRIME of extension term-long A. safety and]), MMSE[
in dosed and randomized were patients 196 of total A: Results
,months 12 After. cohort titration the in patients 31 including, PRIME
assessed as (burden plaque amyloid brain in decreases significant
titrated with observed were]) SUVR [ratio value uptake standard by
[error standard [mean adjusted (placebo with compared aducanumab
,[018.0 [014.0 vs] 029.0 [171.0: -SUVR PET in baseline from change
the by measured as decline clinical of Slowing). 001.0<P; respectively
as aducanumab titrated with observed also was MMSE and SB-CDR
aducanumab titrated for Results. months 12 at placebo with compared
of doses fixed with observed those with consistent generally were
event adverse common most the of incidence The. aducanumab
with compared dosing titrated with lower be to appeared) ARIA(
:Conclusions. carriers e4 ApoE in aducanumab of dosing fixed higher
significant in resulted kg/mg 10 to up aducanumab of dosing Titration
treatment of months 12 during burden plaque amyloid in reductions
compared AD mild or prodromal with patients positive-e4 ApoE in
generally were cohort titration the in effects clinical The. placebo with
the and cohorts1 dosing fixed the in observed those with consistent
with significant statistically was SB-CDR the on decline of slowing
appears aducanumab of Titration. placebo versus aducanumab titrated
this in dosing fixed with compared E-ARIA of incidence the reduce to
ENGAGE the of design study the support results These. cohort patient
the investigating are which 2,trials clinical 3 Phase EMERGE and
.AD early with patients in aducanumab of safety and efficacy clinical
V Viglietta. 2; 56-50:537;2016 Nature. al et J Sevigny. 1: References
.al e
Does anyone know why/how we got this PR today before the embargo time restriction of 8 AM PT? Does it mean we could still get more info today when the actual ABSTRACT is released? TIA
That is my hope, but at the very least, we should be able to see them on the CTAD website. IMO.
Regarding people registered at CTAD, you said
People registered have the info already,
123Tom, you are CharTastic! Nice call on the $3.53. I don't play it that close, or trade that often...but if I do, I will pay more attention to you. Thanks, and good job on your charts. Tomorrow will be an unusual day, with the release of the abstracts; how much detail we see, will it be PR'd with other news or just posted, etc..do the charts go out the window with a day like tomorrow? And then there's Friday...a day after abstracts, a day before the oral presentation. What/how do the charts predict the next two days, and how reliable could they be given the variables?
Is Acadia involved in CTAD this year? I've been looking, no easy way to search program details.
Great News, mono therapy wins, modifications to trial design done as we all hoped. Not taking profits today, too much can happen between now (10AM) and CTAD. Good options pricing this morning, picked up more long calls Dec-April. Go $AVXL
I also appreciate your charting proficiency and guess I'm less focused on the short term moves and more concerned about the bigger picture. I'm always afraid to make a quick sell trade in the hope to buy lower, when the longer term trend and my belief points up. I lost so much sticking with this from the highs, I can't afford to miss a major uptrend. (I know, I just made your point) but rising above the trees, the forest looks like the low $3's is quite a bargain compared on where we were and where we're going. Keep up the charting, it's very helpful. Thanks
Tom, your point of a caution yellow light
I agree with the positive technicals you described....but I think you should not fail to see the resistance overhead as well.
4 weeks until the "news" is a long time for the powers to keep playing games