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All AVXL longs may agree with me your last two posts may be the best
thoughts presented on this message board, THANK YOU!
Thank for your highly competent and knowledgeable view, I am
trying to understand which positive results, Rett or PDD OLE,
has the most impact to AVXL stock price, sure both positive
is the homerun outcome, thanks again.
Can we assume Anavex 2-73 works the same way for all three(Rett, PDD
and Alzheimer) by "Its activation of the protein causes the protein to
take on or resume modulation or facilitation of a number of homeostatic
processes in the neuron."? Thanks for your opinion.
FWIW:
International Conference on Advances in Parkinson's Disease
November 18-19, 2021 in Singapore, Singapore
Notification of Acceptance/Rejection October 28, 2021
Now, it is (IF)AVXL's time to shine at the conference for PDD OLE
data, we can hope! Two of 2-73's competitors, NVS RTT gene therapy
and CRTX's ALD drug, are gone today.
Agree 100%: "dose all patients at the highest dose tolerable for each
individual patient using a very slow titration regimen"
I think the PDD OLE should dose all patients in 50mg since
PDD-001 finds no safety issues and the strong efficacy in
50mg arm, SAVA's simufilam OLE all patients are dosing in
100mg twice daily, and origin PII has two arms: 50mg and 100mg
twice daily.
I guess if OLE actually gets 120 enrolled, that is 90% from
PDD-001, very positive sign, IMO.
PDD-001 time line:
PR on Jan 26, 2020 enrollment reached
14 WK trial end May 2020
Topline OCT 14, presentation NOV 6, 2020
PDD-001 OLE:
Let's assume all OLE qualified and willing patients enroll
in the OLE trail without disruption of taking 2-73 daily
and should be(IMO), the last patient enrolled into the OLE is
May 2020, following 48WK treatments, the OLE trail ends
in May 2021, than it is interesting which conference in
NOV (IF) AVXL wants to show case the PDD OLE data, and
PDD OLE data is 70% predictive of ALD trial outcome,
if the PDD OLE efficacy data is very strong, watch out!!!
I am very conservative but it is hard to estimate peak sales
potential of 2-73, if price 2-73 at 10K/year cost for PDD and
ALD, 2-73 is going to have the highest revenue/year without
a doubt, Humira has the title so far with $20B sales in 2020.
I know street normally give 1 time peak sales potential MC after
PII efficacy data strongly point to PIII and approval success.
Street is waiting for the real proof of concept long term efficacy
12 months data, PDD OLE is the starter, like SAVA's 50 patients
9-12 months interim efficacy data, the real show stop for AVXL
is the P2/3 Alzheimer's data next year, but the PDD OLE data,
if positive, will get AVXL's stock rocking because street has
to price in higher chance of both PDD and Alzheimer's final success,
since PDD+Alzheimer's peaks sales potential may be $10+B, we
can see AVXL trading in what ever you think is fair multiples of
peak sales potential, standard multiple is 2.5 to 3 times after
positive PIII results.
Agree, AVXL and FDA are waiting the PDD OLE data to finish and sign off
the PDD PIII's SAP, IMO.
AVXL only needs to report the topline on primary efficacy endpoints data,
P value which street cares the most, the trial either passes or fails the test
only, rest of detail analysis is just data mining to understand what is
going on. To your credit, Missling keeps talking dig deep into biomarkers
is not giving street comfort of approval based on PII results, IMO.
And why not to do "PDD style chop in two stunt" like last year if
the data is strong positive, it will leak out if having results in
hand and holding too long. PDD-001 trial ended in Sept, topline on OCT 14,
presentation on Nov 6 is right way to inform us all, IMO.
Regarding A-273 prices for RTT and ALS, there is no problem since
there are two different formulation, one is Liquid oral solution
for RTT and Oral capsules for PDD, they are not interchangeable
between RTT and PDD, IMO. As for different prices for the same
drug, I see two examples of LLY's Cialis licensed to UTHR for
pulmonary arterial hypertension (PAH) costing $120+K/year before
the patents expired, and Lucentis for wet AMD and cancer.
Thanks, I bought in yesterday, believe in the data,
but keep in mind AD and PDD are hard nuts to crack, let
along the politics BP play on FDA, in the end, the trial
results should win.
I mean PDD extension trial is OLE.
"This is a Phase 2 open-label extension study to evaluate the effects of ANAVEX2-73 on safety and efficacy of daily treatment."
https://www.clinicaltrials.gov/ct2/show/NCT04575259?term=ANAVEX+2-73&draw=2&rank=1
Interesting timing for PDD extension trial data presentation if AVXL
wants to go to this conference:
Abstracts/Full-Text Paper Submission Deadline October 14, 2021
Notification of Acceptance/Rejection October 28, 2021
Final Paper (Camera Ready) Submission & Early Bird Registration Deadline October 18, 2021
Conference Dates November 18-19, 2021
IMO, the PDD extension efficacy data is going to be very impactful to
AVXL stock, strong efficacy data will force street to price in high
% of final success of PDD and Alzheimer's!
"If he won't provide any other details, which is obviously hurting the cause right now, then I'll assume one possibility is that he's hiding something." This is the golden rule in biotech investing!
FWIW, my reading tea leaf from NWBO management behavior tells me
the new changed primary OS comparing historical control is SS,
the important secondary endpoints are not, but the most troubling
are the OS from subgroups with MGMT methylation status and IDH
mutation status not SS comparing the original treat arm vs placebo
arm, if this is the case which I believe is, otherwise, no need for
NWBO to delay for so long to PR TLD, NWBO may go down less than 50
cents, IMO.
Sab63090, Thank you very mush, you have class!!!
By the way, take a look and do some DD on OMER...you may like it.
Final note: Geert has "lied" to us all along, he "knows" the big
chance of missing the primary OS endpoint target and hitting
the subgroup OS, IMO. If some share holders file a lawsuit
and to subpoena all the communications between CVM, FDA and
IDMC, we may find out CVM and Geert "know" much more than
he say he is "blinded" to the interim results, IMO.
Primary OS 4.9% advantage Vs my estimate 5%...
I call my estimated right on the marker!!!!!
On May 18:
"Pure guess from my reading of stock actions and Geert's comments
in today's letter and AF's yesterday article:
The MK trial may miss the OS P value 0.05, but may produce 5 year ~65%
Vs ~60%, a 5% advantage of HR 0.95, good safety profile."
CVM first sells off, where is bottom? we do not now, we want to see
how strong the full subgroup data first, then argue should FDA approve
or not, IMO. By the may, CLSN first liver cancer PIII trial has a large
subgroup data with OS p 0.02, but the subgroup OS KM curves are
not impressive, so FDA told CSLN to run another PIII again to
test the subgroup patient population.
Does FDA approve for the subgroup set of patients or not?
Depends on the data, the subgroup set analysis in SAP?
Large enough number patients in the subgroup? Any biomarker
data support the OS and prove MOA? Most importantly the how
the subgroup KM curves separate to the end? IMO.
I told you so, CVM and Geert is a classical data mining behavior
regarding the data analysis process, good luck with fighting
with FDA for approval with subgroup efficacy data! CVM may win
or not, let see the subgroup OS KM curves first....
“...study did not achieve its primary endpoint of a 10% improvement in overall survival. However, the OS benefit of 14.1% at 5 years for the lower risk subgroup (no chemotherapy) exceeded the 10% OS benefit set out for the study population...”
All CVM longs should vote NO for 1.8M shares stock option plan,
Geert should PR the data first, then gets his rewards for success,
I do not trust Geert any more, I exited July calls bought yesterday
because the Dr's comments are not about MK after all, good luck longs!
100% Agree, unbelievable find!!!!!!!!!!!!!!!
Reminds me of AMRN's PIII results in Sept 2018,
few weeks before the data PR, AF had a conference
call with a AMRN trial DR and he estimated with 85%
chance of trial success which shocked the shorts of AF.
In deed, A HUGE NEW DISCOVERY....Remember MK trial is open label
and Dr Wise-Draper comments of “we are seeing some really good results”
indicates to me MK trial is a success P value less 0.05, it is just
a matter of how strong the OS is, the delay may be CVM trying to find out
the actual 6 years OS, IMO. I bought some July calls today, I believe
the results may come out after ASM because Geert wants the stock option
rewards priced in $20s on July 2nd before the data PR, IMO.
Geert is not suppose to make the comment of "comparator arms" at all,
it has not been in any other PR before, but why now?
From today's earnings report, Geert has a slip of the tongue, IMO:
"Our Phase 3 study took years longer than expected because it took longer than expected to reach the required number of events (patient deaths) in the comparator arms of the study. It is all about the final data," stated CEL-SCI CEO, Geert Kersten.
It means both arms lived longer than expected, IMO.
FOSCO: "Sorry I didn't catch this statement, and do not know where it comes from
It surprises me a little bit, because as their are blinded they cannot state in which arm the number of event is lagging.
All we know is that events took longer than they should under SOC circumstances
My personal conclusion from trial duration is that indeed there is a longer duration in all arms. The simplest conclusion is that there must be a slightly longer duration in SOC than literature because patients are better cared of and also a noticeable longer duration in test arm to explain overall survival."
Any one listen to NWBO ASM meeting, classical for delaying data excuses, IMO.
Geert commented on good secondary endpoints for approval many times
in previous presentations and even highlighted in today's letter,
good luck to you too.
Pure guess from my reading of stock actions and Geert's comments
in today's letter and AF's yesterday article:
The MK trial may miss the OS P value 0.05, but may produce 5 year ~65%
Vs ~60%, a 5% advantage of HR 0.95, good safety profile.
Technically, according SAP, the trial fails, but a fighting chance???
I do know how street will react to this outcome, I am going to stay
on the sideline to the end to learn, good luck to CVM longs!
I believe AF's view of Geert's last week's conversation. CVM may be telling
CRO to data mining for any positive subgroup data and primary OS may miss
the P value 0.05, all this long delay matches the case perfectly, IMO.
CVM longs at least have to consider the risk of missing OS P value may be
very high now and hedging accordingly, IMO. I am out my 100 35 MAY calls
now, that is all for me with CVM for ever, good luck longs!!!
By the way, even sushi does not say AF is lying, it means he knows the
conversation, IMO.
This one looks bad on Geert, IMO:
Cel-Sci CEO spoke privately with investors last week, raising doubts about long-delayed cancer drug
https://www.statnews.com/2021/05/17/cel-sci-ceo-spoke-privately-with-investors-last-week-raising-doubts-about-long-delayed-cancer-drug/
From Q-10 filed Feb 12:
J. SUBSEQUENT EVENTS
Between January 1, 2021 and February 5, 2021, the Company received approximately $ 3.9 million through the exercise of options and warrants to purchase shares of the Company’s common stock.
and from Post-Effective amendments for registration statement file on Jan 15:
2,345,555 shares of warrants are filed for sale, here are the warrants:
The terms of the warrants listed above are shown below:
Series Exercise Price Expiration Date
HH $ 3.125 2/16/2022
MM $ 1.86 6/22/2022
NN $ 2.52 7/24/2022
RR $ 1.65 10/30/2022
SS $ 2.09 12/18/2022
TT $ 2.24 2/5/2023
UU $ 2.80 6/30/2021
We can see most of the warrants had excised before Feb 5, IMO.
NON-insiders may have used the the squeeze on Jan 27 to de-risk their positions, IMO.
@sab, That is the reason why I bet on big calls for many month for Geert's
surprise topline data PR if the results are homerun OS 23+% and no need
to wait for full data analysis which only for BLA which may take 6 to 12
months to finish depending CMC section. By the way, I bought some cheap
May calls again yesterday betting on Geert can not hold the results too long
if he gets them, the chance of sushi win is very high, but I like to gamble
on my gut feeling.
One great post from Hodag, it is very relevant to CVM:
https://www.investorvillage.com/smbd.asp?mb=6543&mn=14449&pt=msg&mid=21977422
I got out my May calls after I see Geert's tweet, he still
does not have the full data report so far.
Agree, CVM is going to report first, most likely by first week of May,
IMO. Today, CVM action is very encouraging, we may see up to 25 before
the news if the MK trial passes the test, street can "smell" the success...
open trial, too many IDMC looks, two CROs....you get what I mean, too
many people can "estimate" the results already...IMO. From now on, Every
Friday's volume can be telling, IMO. FWIW, Too many IMOs, Lol.
I suspect many funds also get Gavin's estimate too and if
no data PR by May 3 or 4, we may start to see negative
reactions, IMO.