Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Thanks, Kiwi
Now I am much more conservative in terms of expecting efficacy from
this P2 DME data.
Mid of May, if RZLT follows EYPT steps, very likely, very strong interests in PII
with fast and over enrollments which foretells strong proof of concept data,
we may see $500-600M MC, $13-15 stock, IMO.
Thanks for the DD and reply. From the PR on DEC 13th, the statements are as bullish
as they can be, IMO, assume P2 data is strong positive, what may be the fair price
target in your opinion? Thanks to your mentioning on Biotech value board, I did some
reading last night and like the reward/risk, so I bought in this morning.
Kiwi, We see EYPT has an EYP-1901 P2 for DME, Does RZ402 have potential
for wAMD?
Thanks, just bought in last week, just wonder how much RVNC may be worth of a buyout
because the statement of "the value of never-ending profits".
Point that I do not know if you include in the calls RVNC bought to cap
8.9M from the convertible debt at $48.88/share for a buyout price/share.
DewDiligence:
"Botox and the value of never-ending profits"
https://www.evaluate.com/vantage/articles/news/deals/botox-and-value-never-ending-profits
Now, can we expect Daxxify and the value of never-ending profits until a better botulinum toxin
is made in the future?
Talk about incompetent CEO, penny wise dollar foolish, I lost
huge amount money on OMER, another company with a very
good drug, but crappy small open label P2 data creating all
kinds of confusion, delay after delay, year after year, never ending....
Street agrees with you, in the end, Missling is trying to massage the data,
good subgroup data for P3, we are right after all about mixed topline data,
and AVXL may see AD P3 data by end of 2026 the earliest if AVXL starts
the P3 before end of 2023, AVXL dreamers can forget about any type of
approval with this data set, IMO.
Street can smell out PDD ole has failed the primary endpoint long
time ago, if it is positive, we should have had the data end of last year since
the PDD PII trial ended Sept, 2020 and PDD ole is 48 weeks study and should
have ended in SEPT 2021 and results by end of 2021, AVXL did not report any
thing because no positive primary endpoint data, so they have done the data
mining for the whole 2022 in hoping positive AD data, now seems to me,
all they get are failed PII primary endpoint data with some positive subgroup
data, not even a good proof of concept PII data, IMO.
I understand what Missling says on the presentation, He broke his silence
and hinted strong precision subgroup data, that is what collectively street
thinks too, that is my read, I may be 100% wrong, often I am, good luck!
Nothing special, just from my experiences following PII and PIII results
in 25 years, if results are clear cut pass or failure in primary endpoints
they report 99% the time within the time guidance, normal range 6 to 10
weeks, but AVXL is in the league of CVM and NEBO territory of many months
late with all kinds of excuse, no matter what they say, the end results
are what they are, in AVXL case, I have no idea what kind mixed primary
endpoint data may be, but I feel they are just not clean cut SS, IMO.
The hints from Missling is precision implying strong subgroup data
which may be not as a large population as longs here hope for in the
AD 509patients trial, IMO.
Food for thoughts: BIIB and EISAI reported positive topline data and
ROCHE reported negative topline data, both get full section presentations
at CTAD, now AVXL AD topline is so strong so special so in material
in the eyes of SEC that AVXL does not have to PR it first, some where
some things do not fit, I do not buy the reason AVXL does not have the
topline yet, actions are louder than words, only logic conclusion I get
is the primary endpoints are mixed, but some strong subgroup efficacy
data which brings AVXL into CVM and NWBO territory, IMO.
After listening to today's presentation, from my reading between the lines,
Missling signals good subgroup data, ONLY MY OPINIONs, good luck.
DOC, you are right, the way Missling handled PII PDD data release
tells me Missling played games with investors and street, hence
street does not trust him this time until he gives the AD results, IMO.
NO! I am wrong most of the time, stick to what ever you believe.
Positive points: Over enrollment from 450 to 509, very high 94% OLE
and genetic analysis
The problem with me is the positives has not translate into on time
strong positive TLR, my reason is clean and clear topline primary endpoints
P values SS are the only data I cares, rest of them are data mining, IMO.
FWIW, One stupid person's opinion. The 25% is a big increase from close to
0% after I learned and made some money from ATNM's PIII timeline and
very positive topline P value 0.0001. ATNM PRed data base lock on
Sept 21 and topline PR OCT 31, almost 6 weeks data analysis time,
this gives me some hope AVXL may take lot more time for data analysis.
Here is an example about positive subgroup data and how much it is worth
in street eyes:
Subgroup data:
CEL-SCI'S Multikine Reduced 5-year Death Rate From 54% to 22% in Phase 3 Study Patients Who Were Early Tumor Responders Prior to Any Standard of Care Treatment
https://feeds.issuerdirect.com/news-release.html?newsid=6891761220860843
Full topline data:
https://feeds.issuerdirect.com/news-release.html?newsid=8313127790862861
CVM value: $150M
We reason in the same way, hence I bought cheap NOV 18th calls for
just in case AVXL may win in the end even though the chances are low
now, worth the risk/reward, IMO.
Doc, I am 100% agree with your views of late TLR. IMO, AVXL
is dangerously very close to NWBO and CVM, months' late to
report topline data for all kinds of reasons and in the end, mixed
results and street reacted negatively. I am in cheap NOV calls now
for my estimate of 25% positive TLR win, 65% mixed topline and 5%
failure. AVXL longs here may remember golden rules of big trial
reporting rules: good or bad news normally are reported on time
and very very high chances, very late news are mixed at best ,
the only reason for late is data mining for detailed subgroup positives, IMO.
By the way, if AVXL is going to release TLR only at CTAD, my
opinion is 100% the results are mixed.
Tricida Announces the Selection of the VALOR-CKD Trial for an Oral Presentation in the High-Impact Clinical Trials Session at ASN Kidney Week 2022
https://finance.yahoo.com/news/tricida-announces-selection-valor-ckd-123000696.html
DOC, you sum AVXL up the best, we have to be realistic, my view now is 100% in
agreements with your " nuanced results could be $6-20 depending on a lot of
variables and a clear win brings us to 30-100 depending on strength of the results"
and " I want a clear win but actually feel a nuanced result is most likely (especially
since TLD is taking longer than it should)."
At least AVXL is professional and follows industry mode of action
to PR the topline when available.
Good luck. "I don't expect much TLD information to be released prior to the CTAD
presentation." and "If I lose most of my invested capital, I'm out of the investing
business." From my point of view, these two statements from you do not mix well.
IMO, after they have and review topline few days, then AVXL may PR to the public.
Is it material it shows a clear success? We can reasonably to see
if AD failure, AVXL may go down to 5 and if AD success, AVXL
may go up to 50, which is more material in your opinion?
It is possible to turn a P2 into a P3 if the efficacy is very strong for FDA
to agree, but FDA can change their mind after the NDA or BLA is
submitted. This happens to OMER's NASRO for TMA with a
breakthrough designation.
I mean topline data like EISAI and AKRO have done, I am 100% sure
we will read Roche's topline data by mid of Nov, full details of subgroup
data is reserved for presentation, the most important and big market
moving data are the primary endpoint P value, less than 0.05, the trial
passes the test, otherwise all are data mining in the eyes of FDA and
wallstreet, stock will react depending how strong the subgroup data
are, IMO. We can bet AVXL will PR the topline first too if they are going
for CTAD presentation.
Roche's Gantenerumab PIII With Early Alzheimer's Disease (AD) last update
was July 4, 2022 and the Primary Completion: September 21, 2022 [Anticipated],
Roche has about 10 weeks time to get the full data to present which is scheduled
Nov 30, 2022. Roche may have to submit the data set to CTAD review committee
for review first, so ROCHE may have to get the dataset in CTAD's hands by mid
of Nov, the latest, that is about 6 weeks from trial ending to data ready, which
is also the EISAI's timeline. One thing is 100% true company has to PR the
market moving clinical data before submitting for presentation.
https://www.clinicaltrials.gov/ct2/history/NCT03443973?A=39&B=40&C=Side-by-Side#StudyPageTop
Totally agree with your view of the importance of placebo-controlled trials,
hence coming P2/3 topline results, if they are as strong as many here
believe, 2-73 may rock the AD world, on the other hand, a dose of reality
for AVXL die hard longs, AD PIIa data are from small single arm trial, patient
selection plays a very important role here, so the risk of P2/3 of failure
is very real too, IMO.
Yes, CMS killed Aduhelm because if CMS let it pass, the demand is there
and the cost may bust Medicare buget, IMO.
Clinical relevance is for patients to judge, take a look at SRPT's
EXONDYS 51 which was approved with so much and so many
against the approval, but DMD patients demanded, now a commercial
success, IMO.
Thanks, I did, I read CTAD program file last night and
found out BIIB and Roche presentations were set before any data ready,
so I was wrong about data first, and bought back this morning.
attilathe hunt, now I believe what your understanding regard to AD P2/3
data late-break is correct, I find out Roche's Gantenerumab PIII
scheduled for CTAD presentation, but the results are not available
yet, so it is possible for CTAD to set a time slot of LATE BREAKING ORAL COMMUNICATIONS for AVXL too without the data submitted by today.
Wednesday,
NOVEMBER 30
3.00 p.m LATE BREAKING ORAL COMMUNICATIONS
3.45 p.m Coffee break and poster session
4.15 p.m Topline Results of Phase III GRADUATE I & II Confirmatory Trials with Subcutaneous Gantenerumab
5.15 p.m End of the Conference Day
https://www.ctad-alzheimer.com/files/files/ProgramPrel_CTAD2022_16%20aout.pdf
GRADUATE 2 (NCT03443973)
https://www.clinicaltrials.gov/ct2/show/NCT03443973
GRADUATE 1 (NCT03444870)
https://clinicaltrials.gov/ct2/show/NCT03444870
Thanks for our understanding, it is best I end up regretting my decision
big time, the potential is there for that and I am going to watch AVXL
every day until topline news, good luck to all AVXL longs!
Thanks to attilathehunt for informing us the content of conversation
with AVXL IR, I read no CTAD late-breaking news and I do not buy
the CTAD news pending accepted, I follow my plan and exited my
position this morning, I bought in only for CTAD late-break news
which implies topline success, good luck AVXL longs.
You have given too much credit to Missling, SAVA CEO at least
put his own money down on his convictions and release timely
first 100 patients 12-month data from ALD OLE which has shown
some efficacies.
What is the best time for CEO to PR the topline assuming positive?
Is any bonus for him reaching any milestones in fiscal year 2022 ending
Sept 30, Friday? Or better deal for him in next fiscal year 2023 starts on
OCT 1?
Finally, AVXL shows some life in options' volume:
Bid Ask B/A Size Volume Open Interest
0.65 1.35 1111X105 1,008 1168
Last Last Trade Net Change % Change
1.20 2022-09-28 11:39:32 CDT 0.3081 34.54%
Open Prev Close High Low Time Value
1.20 0.8919 1.20 1.20 1.20
Some one spends $120K bought 1K Jan 30 calls in one transaction.
One very positive sign for good P2/3 ALD topline data
is the enrollment over 13% more than planned, 450 vs 509, this means
the trial is very well powered to show very low P value if 2-73 works
and more important is the trial was in demand and word of
mouth about 2-73 working was going around, IMO.
Here's what Wall Street analysts are saying about the lecanemab clinical trial (list courtesy of Bloomberg):
BMO Capital Markets (upgrades Biogen to outperform from market perform)
The topline data is "as strong as can be," writes analyst Evan David Seigerman, and diminishes the possibility for CMS to deny broad coverage of the drug once approved
Expects Lecanemab to win full FDA approval
Baird (upgrades Biogen to outperform from neutral)
The reported study data is pretty much a best-case scenario, says analyst Brian Skorney
This should not only lead to approval and reimbursement, but could make it challenging for competition to match
Barclays (equal weight-rated on Biogen)
Lecanemab results were "clearly positive" and exceeded most Street expectations, and likely de-risks approval, writes analyst Carter Gould
Provides Biogen with a path toward a return to growth against backdrop of a declining core business, and is a positive read- through to Eli Lilly's chances for donanemab
Raymond James (market perform-rated on Biogen)
The study was a "clean win" and close to analyst Danielle Brill's best-case scenario
Topline data looks to be supportive of full FDA approval and CMS coverage
However, analyst is looking for more clarity on several variables
Cowen (outperform-rated on Biogen)
The topline data appear to be a best-case scenario, writes analyst Phil Nadeau, adding it positions Lecanemab as a blockbuster
SVB Securities (outperform-rated on Biogen)
Study results "clearly great news" for Biogen, writes analyst Marc Goodman, who expects the results to reinvigorate the Alzheimer's treatment space
IF AVXL's P2/3study was a "clean win" and close to best-case scenario,
AVXL may rocket up to $100.
May be, but I have two huge win this month, AKRO and BIIB,
let's see what AVXL has.