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.
sushi, thanks for bringing the DD of Geert pulling out
next week's presentation, I think why not bet some cheap
Mar calls again, so I bought few hundred, sooner or later,
Geert has to report the results in MAR, APR... good luck!
CVM is sure strong today!
If the subgroup is large and efficacy is strong enough
like a "cure", it means OS KM cures have long and diverging
tail and should drive the P value into SS, hope you are
right and this should be good results street will like to see,
and logic is it should not take so many month more to get
the clear picture, CVM already knows HLA is the biomarker
to look for and the HLA data should be in the data base, IMO.
Now, we agree CVM is hunting the subgroup data to support
the BLA and approval, if the primary OS endpoint P value
is not SS, CVM is going into BIIB's zone, FDA may still approve
MK with targeted label, but during the whole approval process,
street will not like it and may give CVM much lower valuation
multiples until CVM gets the approval and show me the sales
growth, finally CVM and NWBO are identical twins now, the
timing of data is real unclear, what is Geert going to do
when he gets the full data set and it has many issues but strong
subgroup efficacy, is he going to follow NWBO to publish the
data and submit the BLA(???) first and then PR the data?
I am OK, I just gave back some of my huge CVM profits,
I only have big OMER options in my account now, I am
going to be very conservative this year because I think
market is in the topping process, You and all CVM longs deserve
a win with CVM, I may come back in only I feel confident
of the results and timing if Geert gives new information,
guess I just got lucky so far with CVM, want to keep the
huge gains, Cheers!!!
I am ready to give up TLD this week, but I will wait until
Thursday morning, let the deadline Feb 17 pass without news
first, to admit 100% sure I lose the bet. Sushi, you won, I will
watch on the sideline for now and wish good luck to CVM longs.
Believe me, the most import data is primary OS endpoint HR,
P value and the OS KM curves. IF MK data is "knocked it out
of the park so big nobody will believe you unless you dot every
i and cross every T", it is so simple, cave man can do it, LOL.
I think Geert underestimate the Wallstreet collective brain power
to understand the data set.
The problem I have is Geert make the data analysis sound like
so complex it takes a genius, but it is not. The time consuming
part is the data scrub and cleaning part, once the data base
is locked, all the endpoint data are represented in numbers
in the data base, and they are pre-specified and agreed with FDA,
CRO should be ready with all the software modules ready to run
the data base once it is unlocked and unblinded, these endpoint
data should be printed out in minutes, rest of called detailed
full data are patients profiles, safety data, any imbalance of
enrollments, subgroup data of geography, reoccurrence treatments
like how many have Keytruda...I can do it in days, I do have
a degree in computer science. Please take a look at the example
Sushi give us and see if it need 4 month to do the job, especially
Geert says experts are doing the analysis which means CRO has done this
kind of job tens or hundreds of times:
https://www.dropbox.com/s/cnku7it96z42mg5/Baas%20et%20al.%20Meso.%20CM%20743.%20IASLC%20WCLC%202020.%20Oral.pdf?dl=0
Most of the knowledgeable NWBO longs agree NWMO management
got the full data between early NOV to early DEC, no TLD PR
is because they changed their plan to publishing the data
with TLD at the same time.
You are right, indeed Geert may show us CVM AND NWBO are twins
after all! We are taking a class of how PIII data analysis and
reporting which are breaking all the industry standard practices
in real lime, IMO
Yes, I did, I have to say only a lawyer biotech CEO can
and will do what Geert is doing. CVM is a very unpredictable
biotech company to read, CVM was invited to JMP conference
last Jan and did not so this year, and does not going to
BIO CEO conference this week and Geert went last year. I notice
Geert does not use soon or close in his recent tweets now.
If no TLD this week, I am going to watch Geert's tweet and
decide what to do next, the base case is MK trial is a success
but how strong the efficacy will be, my confidence of home run
efficacy HR 0.7 or less and P value 0.001 should take hit.
Good luck, and Cheers!
Thanks, but I am no better than any one on stock message boards, I have a open
mind to learn from any one who share their DD positive or negative,
one very good example and very relevant to CVM is good discussions
going on now at I-hub MWBO board, it is very good education for
people interested in expecting PIII results. Read every posts
from the discussion threat, very insightful:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=161013809
sushi, I feel relieved you are not the few chosen one to
leak out CVM's plan of how and when to PR the data like NWBO has,
NWBO never officially informs the market they have changed
the plan to PR TLD to publishing the data, but leak to few
of their friendly investors on the phone calls. At least,
You and I are guessing now, my chance of something happening
with CVM data PR next week is not ZERO. By the way, NWBO is breaking
many data releasing protocols, IMO
Cheers!!!
CVM did pay consultants with stocks:
"During the three months ended December 31, 2020 and 2019, the Company issued 15,044 and 15,819 shares of restricted common stock, respectively, to consultants for services. The weighted average grant date fair value of the shares issued to consultants was $12.45 and $7.18, respectively, during the three months ended December 31, 2020 and 2019."
Yes, I suspect many already can "guess" MK trial
may have approvable data, the whole open label trial
and CVM production planning involve too many people
and it is very hard to keep quiet.
10-Q: "In August 2020, the Company entered into an amendment to the San Tomas lease agreement under which the landlord agreed to allow the Company to substantially upgrade the manufacturing facility in preparation for the potential commercial production of Multikine. The estimated cost of the upgrades is $10.5 million, of which approximately $6.7 million has been incurred to date. Pursuant to the amendment, the landlord agreed to finance the final $2.4 million of the costs incurred, i.e., after the Company has financed the initial $8.1 million. Per the terms of the financing, upon completion of the project, the $2.4 million will be repaid through increased lease payments over the remaining lease term."
This may prove my point I posted here before that FDA may allow IDMC
to inform CVM the trial may succeed in the final data, which allow
CVM to prepare commercial production in advance of BLA, the question
left to answer is how strong the OS data is, IMO.
Interesting conversation about subgroup positive data:
That’s the central question in the aducanumab review, as well.
— Adam Feuerstein ✡️ (@adamfeuerstein) February 11, 2021
Interesting times….
My TD Ameritrade screen is showing Q1 earnings report
after market close today.
I have been in biotech investing for 30 years, and you
think I do not know BLA applications, LOL. My post to
you is let's see MK pass the primary OS endpoint first,
everything else is second important, when the data base
is locked, the trial fate is sealed for ever, you can
analysis the data down to each patient will not change
the picture of: is the trial primary OS endpoint P value
less than 0.05 or not.
If you look at this way, 4 month data analysis indicates "weak"
"muddy" data, like NWBO is doing right, looking for KOL confirmation,
which contradicts your view, IMO. By the way, this is possible
because MK trial has some unqualified patients enrolled which
may messed up the OS data, NWBO's crossover should muddy up the
OS results, IMO. If your view is true of Geert, I do not know
what to say, may be good luck on one person against the whole
industry.
I respect your research and keep your view in mind when
I deal with CVM, but I am more of gut instinct kind player
when it comes to time of data PR. Unless Geert want to go
the way of NWBO, publishing the full data at a medical
journal, he can not miss the ASCO, the biggest stage for
cancer PIII data, you believe two month is not enough time
to get the full data, I believe otherwise, that is the
difference between us, Cheers!
I do not want to say what I really think of him,
I have seen DNDN's and SRPT's CEOs fighting with
wallstreet and FDA for approval, but Geert tops
them all, he has added another dimension, psychological
games, The Art Of War, like you say, "A bit twisted".
There are things in plain view but people does not
want to see, it is very simple, so people think
that can not be that obvious....
Two things I am 100% sure, CRO has finished the full data
analysis and Geert is executing a plan and he is playing
US and street with psychological games now.
For people like to use NWBO timeline as an example of 4 month
or more, here is the NWBO time line:
Data locked on OCT 5, and according to sentiment-stocks:
"So let’s make that couple of weeks 4 weeks, taking us to November 4. However, Linda Liau spoke on November 6 and indicated to listeners that she was still blinded. It’s possible that management kept her blinded for a few more days, given that she was giving a public presentation; however when she next spoke at the Boston GBM conference (costing $2k to attend virtually), and she was probably not still blinded then. So let’s be really generous and make a couple of weeks equal five weeks, pushing the general unblinding of management and their advisors to November 11. I will note, here, however, that management had begun pointing to the 10/5 press release citing that passage about the public announcement and scientific publication around 11/05. Which argues that they had already arrived at the decision to go the direction of a journal by then. And it was sometime soon after that Linda Liau pulled her presentation from the SNO website."
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=161709089
We can see by Nov 5th, NWBO management has the full data and change
their mind from PR TLD to publication, it takes only 4 weeks for CRO
to get the full data, here it has been 8 weeks since CVM data lock,
full data should be ready, it is my speculation CVM wants to submit
a ASCO abstract which takes a little more time and next week may be it, IMO.
Sushi, Please ask CVM why not going to BIO CEO & Investor Digital
Conference February 16-18, 2021, CVM has been to the conference
last 3 years, and not this year, I have my guess, wonder why?
It is too early to talk about BLA, here is the steps:
1 Get the trial pass the primary endpoint FIRST!!!!!
2 Present the data at major cancer conference(2 to 3 month)
3 Meet the FDA for BLA plan meeting to agree what needed for CMC and data(3 month time)
3 File the BLA(normal 6 month)
4 FDA accepting BAL (2 month)
6 FDA priority review and approval(6 month)
Step 2 and 3 are going at the same time
Added 140 Feb 35 calls for 60 cents/share today, I like the
risk/reward ratio!
Last year on Feb 10, CVM issued Q1 earnings report, now
we are at this time again, do we read anything interesting?
We appreciate you share your DD, my bet is certainly very
low chance bet, agree to disagree, good luck to all CVM longs.
OT: Robot, Good buy TLRY at 17, I think some funds are in big trouble
with TLRY and APHA merge complex positions, plus more than combo
47M shares shorted.
Thanks, I read your and Fosco's every posts, got it.
I will stick to my opinion of if Mar for full data,
zero chance of OS advantage of 20+%, homerun results,
if home run results, Geert may want to show case the
breakthrough data at ASCO, if in Mar, Most likely outcome
is "weak" positive HR and P value, IMO. Hope
NWBO releases the results before CVM does and we can see
why NWBO is delaying the PR for so long.
To me, it is a test of P value 0.01 or better homerun
results OR weak P value 0.05 next week.
Why are you so sure data in March?
If that is the case, CVM has gone NWBO's mode,
CVM and NWBO have lot of things in common,
and it is not a positive direction, IMO.
What is it? Share with us, thanks.
@sushi, do you get the reply from CVM IR about the
question ASCO abstract submission? Thanks.
Thanks for the reminder, it is the Presidents' Day.
To your credit, I may be foolish to believe Geert's sense of
time, to him, "soon", "very soon", "close" and "very close"
do not have the same meaning we look up in the English dictionary,
I may be very wrong again just like so many times before, but I am
addicted to CVM monthly calls....guess I am a fool who never learn!
One other risk factor: We CVM longs all seem so sure of the
results positive, we have to consider trial failure too how
ever small chances we think, strange things do happen with
PIII trials......
This is just one clue the data is very close, another
one, remember "DATA in JUNE?" on the radio interview?
Yes, there is another deadline for late-break abstract on
Mar 18th, I still believe 2 month after data lock is more
than enough time to get every thing done, Geert also says
this: "I want to ski with you. It is my favorite sport, yet,
so close to the end of our Phase 3 study I cannot risk getting
sick. That would be simply stupid. Enjoy." on Jan 28th.
All good, as long as CVM wins.
My guess is next Monday morning(most likely) or Tuesday morning.
It is a gamble based on my reasoning Geert wants to
show case MK data, and enough time for analysis, all
my reading tea leaves point to that logic conclusion.
WARNING: after all, it is a GAMBLE ONLY based on chances
not facts, win or 100% loss nothing in between!!!!!