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Here is a simple math estimate of OS:
Enrollments: 135 up to 2013, 196 in 2014, 340 in 2015, 260 in 2016
there are 800 patients for SAP analysis, 400 for MK+SOC, 400 for SOC, 800/930=86%,
135+196+340=671X0.86=577 patients have 5 years, and SOC OS 37%
which should produce 577X63%=363 events, 260X0.86=224 patients have
4 years, and SOC OS 42%, 224X58%=130 events, total 363+224=493 events
if MK does not work, we know the trail has only 298 events, so the
trial produces SOC OS 1-(492/800)=38.4%, the real MK trial OS is
1-(298/800)=62.7%, logic conclusion is: SOC does improved a lot
that help patients live much longert(trial fails), OR MK really
works well for lot of the MK+SOC patients(Strong efficacy), or
combo of SOC improvments+MK helps too(trial may be win with
weak OS HR or fail), I bet MK WINS big!
Dates to Know for 2021 ASCO Annual Meeting:
FEBRUARY 17, 2021 at 11:59 PM ET
Abstract Submission Deadline
MARCH 18, 2021
Late-breaking Submission Deadline (Abstract placeholder is required by February 17 deadline)
https://meetings.asco.org/am/dates-know
Now you know where Sushi's estimate of timeline comes from(IMO),
and I agree with him, most likely later Jan/early FEB.
Again, some one on Rogan show asks(Laughingly) Geert if data come in June,
to me, it says a leak that street already knows CVM plan to present
the full data at ASCO 2021 in June, and it makes sense and logical
CVM wants to present at ASCO, IMO.
I have TLD by mid of Feb, if Geert can not make it
to show case first of kind SOC cancer drug at ASCO,
the biggest cancer conference in the world, some
thing is wrong and all Geert promises of "create a
new type of cancer drug." is just that, empty talk, IMO.
The checkMate 743 trial full data was presented at 2020
Presidential Symposium on Aug 8, the deadline for abstract
is few month early, may be in June, BMY should has the full
data by the deadline of abstract submission. We can see it
took about 2 month or less for the full analyses. Take a look
at another conference LASLC had last year, the abstract time line:
https://wclc2020.iaslc.org/call-for-abstracts/
Does any one know who is the lead investigator for MK trial?
It is not listed here:
https://www.clinicaltrials.gov/ct2/show/NCT01265849?term=Multikine&draw=2&rank=3
My prediction: CVM may want to present the full data
at ASCO Annual Meeting JUNE 4-8, 2021, and the
deadline for regular abstract is Feb 17th. If MK trial
is a big success as Geert thinks, MK should be the star
of the meeting. Remember some one joked on Rogan interview
that results will come out in June, it tells me street
knows the full data at ASCO presentation, IMO.
DO NWBO longs think what will happen if only the new primary endpoint
is positive with P value 0.04 to 0.05 and 4 or all 5 secondary endpoints
are not SS?
I greatly respect DD's knowledge and his willingness to share
his view when asked, there are many I have followed for more than
10 years. About CVM's data read out, Geert is the problem with
misleading comments of "soon", "very soon" and now "one morning
wake up, here is data", may be he does this on purpose, on the
other hand, he does give us strong hints MK is a success.
Agree, that may be the case with NWBO, I will give CVM
until early of Feb for TLD. But these two are definitely
not following the usual course of business as we know.
W-W, You are 100% correct, It is that simple, all the data are numbers,
CRO just has to define the conditions and run through the data base,
come out all the tables like Sushi give the example in the Dropbox,
the primary endpoint and secondary endpoints are pre-defined in SAP
approved by FDA, rest of the subgroup data are defined by mostly enrollment
Inclusion Criteria, that is all, nothing complicated. IMO, NWBO data
are muddy, NWBO's new primary OS endpoint may be weak positive
like P 0.04-0.05, but 3 or 4 of the secondary are not SS, and that is
why NWBO is holding the TLD, trying to find a way to present them
a positive way, but The best writing skills or a perfect presentation cannot
compensate for a trial with weak data set! If MK has strong efficacy,
the full data set is clean on all points, take look at the primary OS endpoint
KM curves in Sushi's dropbox presentation, what a beautiful picture,
separate early and consistent gap to the end that produce a low P
value 0.002, if MK trial produces the OS KM curves like that one,
HR 0.74 P value 0.002, CVM hits the jackpot, homerun results, and
CVM stock tests 100 on the first day after the PR, IMO.
CVM and NWBO may be deliberately withholding topline data now, IMO.
CVM says waiting for full data analyses and NWBO says waiting
decision to publish at a Reputed Journal, I have never heard
that kind of reason from a small biotech company, thanks for
your help.
DewDiligence, I have a question regarding ASCO abstracts,
which presentations is more impactful at ASCO? The regular
or late-break abstract? This question I ask is about why
NWBO and CVM are delaying PR the TLD, the reason may be
which ASCO abstract they want submit to ASCO, IMO. Thank
you for sharing your expert view.
FWIW: I guess Geert does not care ASCO too...but here it is...
Call for Abstracts
2021 ASCO Annual Meeting (June 4 - June 8, 2021)
Abstracts may be viewed and modified at any time between submission and the deadline (Wednesday, February 17, 2021), by the designated submitter or the first author.
Mk trial is a simple one for data analyses, here what a complex
one looks like, also for head and neck cancer:
2 primary endpoints and 15 secondary endpoints:
https://www.clinicaltrials.gov/ct2/show/NCT02252042?term=Keytruda+Neck+cancer&draw=3
CRO should not take long to get MK full data analyses done,
if it has strong efficacy like Geert says today, we should
get the TLD PR "soon", IMO.
"Geert, what will we think of him, once this is over?"
IMO, Geert should be CEO of the year biotech award or
on top list of all time snake oil salesman.
I like today's presentation, He said it at the formal
conference today that He knows more than anybody about
the trial and it should be a success! From my experiences,
that is a strong hint to us to hold the position for good
results.
Agree, He has done lot of DD and shared his views
with us, thank you, sushifishman!
Finally, Geert admits he knows more than he can tell...
“If you are involved in something day in and day out for ten years you
have a much better sense of how things are going than anyone on the outside”.
It seems Geert wants to follow AMRN's foot steps of
in bed with street to kill all the Jan calls above 15
by releasing the data on Jan 18. In Sept 2018,
AMRN had 22+m shares in Sept calls expired on Sept
21 and AMRN held the data to PR on Sept 24, Monday
morning, some how what goes around comes around to
AMRN back to 5 again now. One thing is proved to be true
that AMRN CEO insisted that interim looks did not stop
the trial was because AMRN wanted the secondary endpoint
of mortality rate to mature and show SS efficacy,
and this may be happen with CVM too that Geert keep
saying 298 events for true MK OS efficacy. Any way,
the data should be ready by now, using Geert's own words
in today's letter:
"experts are now analyzing the data according to a statistical analysis
plan that was agreed to and finalized before database lock."
VERY IMPORTANT: " a statistical analysis plan that was agreed to and finalized before database lock"
after data base is locked, CRO should unbline it, run software through it
and print out the results, without the primary OS endpoint being
SS, the trial fails, period!
Interesting Geert said "Happy new year!" yesterday,
wild guess he know he is not going to tweet today,
may be finally data arrive today and PR next Monday
for big fireworks on the first 2021 trading day,
let's say the chances are not 0, IMO.
May be I read too much into the comment...it is kind
of scary Geert is so confident of MK success...since I
am loaded with CVM, guess it is a good thing, if the
final results is as good as Geert says to increase cure
rate to 60%-70%...hard to think how much street is going
to reward CVM, too good to be true...
By the way, you are right about who he is speaking to,
check out Rense program...wonder why Geert is going there.
One thing I really do not like is Geert's comments of comparing how many
death one group to another group is so idiotic, I have to remind Geert
that, to FDA, the primary OS endpoint is pre-specified in statistical plan
and the p value has to be statistical significant for approval, the sub-
group data how many patients can be cured is not in SAP for approval but
only meaningful for marketing purpose, IMO.
Please listen the interview again, pay attention at time market 35 to 36
minute, Geert should know better, what do you think?
Me too at little less, but sold all at $1.75-2.25,
good luck with your NWBO position, it is hard to know
how street will react to the muddy results, my base
point is street has price in a muddy positive results,
the question is as AVII has commented what FDA is going
to do with the data.
Any one holding NWBO or thinking buying NWBO for final
results should read AVII's post starting from posts at
12/17/2020 on NWBO IHUB board, I have followed him/her
posts for more than 10 years.
https://investorshub.advfn.com/boards/profile.aspx?user=555194
And you may get a sense of why NWBO delays PR final data for so
long, if any one think CVM waiting for full data to PR news is good
news, think twice....By the way, I am betting on TLD by first week
of Jan 2021, but starting any day next Monday for a clean OS primary
endpoint success, any thing else is data mining to FDA.
IMO, Geert is master of games, his daily tweets recently have a purpose,
he has been silent for two days, if my read is correct, Geert may PR TLD
any day from next Monday on condition the OS primary endpoint has highly
statistical significance and FDA's approval is close to be guaranteed,
after all, OS endpoint is the GOLD standard for cancer trials!!!
Only thing I can say is people are not angles and they talk too,
Geert has reasons to be 100% sure the trial's data without mistakes,
there are forces want MK to fail, IMO.
Take look At ATNM and read PIII interim data, ATNM's
PIII trial is open label too, it does not break FDA's
rules to know the open label PIII interim results.
Geert's confidence is off the charts, I have to believe
CVM's internal modeling OS indicates very high degree
success, plus the trial is open label...use your logical
thinking...the question is how strong OS data will be,
the topline data may come soon if OS p value is 0.001 to 0.03,
CRO should have them already, IMO.
Thank you for the timely call and share the new information
on the board.
Another reason CVM has to get some money now is the Q4
SEC filings, CVM may have about 12M and accounting auditor
needs one year operating cash on hand to sign off to avoid
the going concern, IMO.
Wrong, NWBO has been sitting on the data for more than a month
now(IMO), once the data base is locked, CRO can unblinded it,
run through data base with pre-programed modules for primary
and secondary endpoints immediately, gets all the endpoint
P values in minutes, the most important P value is the primary
endpoint OS P value, if it is less than 0.05, it is a success,
otherwise, all other data analysis are data mining. To me,
NWBO's final data even with the new endpoints are muddy at
best and NWBO are data mining for the best subgroup data set
to color the results and fight for FDA's approval, at worst,
NWBO may be delaying the data PR to let the warrant holders to
short the NWBO at $1.20 to $1.50 to cash out, IMO.
Geert may be playing games with shorts by saying one thing
and acting differently with PR when milestone is reached,
now I am confident Geert may issue the topline PR when
he has the data in hand.
If OS advantage is 20+%, Geert may has on choice to PR
the topline as soon as he gets it, any way, all good
for CVM longs, small chance topline PR next week, Dec
option week, the buying pressure may even stronger
if strong data, IMO.
I bought back in again this morning, if the OS primary endpoint
P value is less than 0.05, less the better, in FDA's eyes, the trial
is a success with 99% chance approval, CVM may release the topline
data in two weeks, most likely day is Dec 21, ICON may have the OS
% and P value today, but CVM may want to kill all the Dec call options
above 15 if Geert thinks most of calls are hold by shorts for hedging,
any way, we may see CVM back to 15 to 18 before topline by Dec 31, IMO.
This kind of fluffy news makes street suspicious if CVM
is looking for after life of MK failure and CVM stock is
down today and market is up huge, CEO Geert is not doing
CVM longs any favor with empty tweets, PR some real news
about MK P3 trial that will help, IMO.
If FDA agrees to stop the trail for approval, that is
most likely way for final data analysis.
I agree with your view, that is why CVM needs clean OS P
value less than 0.05, less the better, to gain FDA's approval,
otherwise, the fate is questionable.
I never short any stocks, always betting on positives
data, why don't you offer your opinion on why Geert's
comments why FDA needs SEER and historical comparisons
for IT-MATTERS?
FDA has hard a decision to make, on one hand, the data is
showing convincing efficacy, the science is solid
behind the data and the medical KOLs should ask and support
stopping the trial for approval, on the other hand, FDA
has to be flexible. I am betting on FDA making the right
decision and stop the trial to file for approval.
Doing my DD, thinking buy back in or not at the right
time in Dec. Now to me, NWBO's and CVM's primary OS
endpoint data may not be clear cut approvable to FDA
and may be controversial.
Do you see Geert's answer something not normal on Tweeter?
Michael Taylor: this might be the Quarter they report the P3 Multikine study that Reached the Required Number of Events IN MAY. (and I still wager that they will switch the Pbo group to historical control in the name of Covid) Which means, the study flat out failed, years ago.
Geert: This is drug development. There are rules despite what you say. Look at FDA guidance and you will see that FDA wants to see ALL comparisons (e.g. study control, SEER and historical) plus have the electronic data base so that they can analyze the study in any way they desire.
MK trial has a control arm, why do FDA want to see SEER and historical
comparisons? Does it mean the primary endpoint is not SS? To me, this
is a clear sign CVM is data mining now and CVM is doing exactly the same
thing NWBO is doing, interesting Geert did not defend CVM against Micheal's
comment of "the study flat out failed".