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latest we will get an update is mid of May Q2 earnings report, IMO.
Sushi, We have passed the stage of 900+ patients and lasted over 9 years
and 5-6 months to finish a Full Data Analysis, I am asking a question
why it takes another few months to PR the data after Geert receives
it, if Gavin is to be believed of estimated full data ready by Apr
15, why can't Geert PR the data in days instead months. Do you get
the same answer as Hopeforthefuture3 does?
The simple and logic way to think is small biotech companies want
to share good PIII data as soon as possible for many reasons, to
raise money for FDA submission, prepare CMC, patent life clock...
and once data base is locked, the trial's fate is sealed, the
primary endpoint and secondary endpoints and all other data
can be searched by spreadsheet software, the tables, graphs, HR
and P values are easy to produce from numbers in data base and does
not take months, IMO. To FDA and street, if the primary endpoint
misses the P value, more than 0.05, the PIII trial is technically
failed, it does not mean FDA will 100% not approve the drug, but
company has to fight for the approval and street may not give much
value to the drug until after approval, IMO.
Then You are saying Gavin does not know what he has told many investors
on the phone calls. I know you may say it is just an estimate, but
my question may be: Does Gavin give out estimates out of thin air or he
is out right playing game with us like NWBO has been doing for years
on timing of trial end and TLD?
We may see CVM hit 100-120 if Geert report great results, street
and MM may take this chance to squeeze shorts to push over 100 to
short CVM themselves because they know CVM may have to issue
$250M to $300M stocks, look at SAVA, went from 23 to 117 in 3 days.
I am trying very hard to find reasons why Geert may hold the data for
many months, my small May call position is based on Gavin's
estimate of full data ready by Apr 15 and clear strong efficacy
of close to Fosco's 23% OSI which should produce OS endpoint P
value 0.01, a home run results and data PR in days after Geert gets
it, I guess I do not take my own view of Geert, a lawyer, serious,
my fault....I can only come up "weak" OS data for another multi-
month review of the full data by Geert and CVM.
Regarding NWBO valuation after data PR, you only have to look at
BIIB, after even FDA defending BIIB's BLA, street is giving very
low valuation for chance of approval, but I thing FDA will approve
BIIB's drug in the end. I have admitted I have been wrong many months
about Geert's intent on tweets about timing of data PR, I do believe
you have a better sense of when, thank you for the heads up, I guess
I have to change old habits....
It seems to me NWBO is trying to submit BLA to FDA and UK first
and after one of them accept the BLA to PR the data, I do think street
will not give NWBO much higher valuation before one of them approval,
I believe NWBO stock price has priced in most for hitting the new
OS endpoint with P value < 0.05, NWBO may be swing in 1.25 to 2
before approval, IMO.
I used to believe Geert 100%, not any more, but I still
believe Fosco's estimate has a good chance of close to the
real data, it is why I am still in the hunt for good data.
I keep coming back to NWBO as an example, if MK data is barely
positive with many conflicting subgroup data, it is not hard to
think Geert may follow NWBO's model of looking for KOL's support
and validation first and PR the data after, keep in mind CVM
and NWBO CEO are lawyers, they are not normal small biotech
CEOs, I jus think they over estimate their power to over come
Wallstreet and BP forces if the data is weak like DNDN, IMO.
By the way, I still think Fosco's estimate 23% OSI is believable
and after Geert get the data report, he may PR in days. My issue
is if Geert holds the data PR for up to 6 weeks after he receives it,
it sure indicates weak data to me.
Let's assume GAVIN's estimate of full data ready by APR 15
and Fosco's 23% OSI prove to be close, it may be a joke CVM
takes another 6 weeks to ask around what do you think about
our homerun results of "Is it too good to be true?", Lol.
No outsiders can verify the results, only FDA can do it
with the full data in data base after BLA is submitted, IMO.
Thanks to you, correction, I sold all 850 Apr 30 and 35 calls
with about 50% loss on Monday after your article hit the market,
not too bad. Cheers, the march goes on!
sab63090, I closed out the Apr calls yesterday, thanks to sushi,
other wise I may have 100% loss. If no news on Monday, Apr 12,
95% no news on option expiration week, IMO. I have to admit I
can not figure out Geert, so my guess is worthless now, any
way, bought initial position of 100 May calls yesterday,
just in case...who knows what will happen??? I am totally
blind now, hopefully like a broken clock...
Thank you for helping us out who do not call Gavin, I am fully aware
the risk of missing the PR of data by April 16, we all appreciate
you inform us what answers you get from Gavin to your questions.
Good luck to you and all CVM longs!
I believe in hopeforthefuture, he is a honest straight shooter. Many
other called Gavin, either did not ask the right questions or do not
want us to know the real meaning of Apr 15, IMO.
Look at the other way, many funds called Gavin too, hence the
huge 10M shares of Apr puts are insurance for longs
and doubters bet on failure, and calls for 5M shares are
short hedges and longs bet on positive data in case PR of data
by Apr 16, IMO. By the way, most of the calls and puts are bought
at much higher prices than dimes today, I watch CVM option
volume every day real time on my streamer. I AM NOT saying
PR of DATA 100% sure thing next week, just that GAVIN at last
gives a ESTIMTED time guidance of data ready by APR 15, rest
IS GAMBLE!!!
Hopeforthefuture3, thank very much again for the confirmation of "April 15 is an
estimate when everything is to be completed by cro/staticians", PR data
or not next week is up to Geert, IMO. This is a simple matter, why sushi
makes so mysterious, PR of data or not next week is up to any one willing
to gamble according to own risk appetite, IMO. If there is PR of data,
I think it should be TLD only, full data set is reserved for conference
presentation, IMO.
Do you get the answer of Apr 15 is the estimated date full data
may be ready? For seasoned biotech investors, normally, completion
dates to any other PIII companies are meaningless, no one even cares.
I think Geert is in the league of NWBO's CEO.....
sab63090, thanks, I believe in Hopeforthefuture3's understanding of "this
date is an estimate of when will have fully evaluated study results
complete and ready to make it public", phone call with Gavin, the big gamble is
if data ready, Is Geert going to PR the data next week or not? IMO.
By the way, I guess(very speculative guess, NO FACT to back it up, to
who it may concern) CVM and Geert may have the full data report now
under normal cases, give your self some spare time.
Sushi, relax, I am the only one here betting on data by Apr 15 with
Apr calls and speculate Geert may play games with the timing
of PR data, some times we have to expect the unexpected to win
big with cheap calls, we all did not expect CVM to go up to
40+ in Feb with out PR of data, but it did, rest is history....
Regarding close out calls, yesterday there were 1378 Apr 30 calls traded
and open interests were 14554, today the Apr 30 call open interests are
14079, so 475 Apr 30 calls were closed out yesterday, FWIW.
Thanks and I believe you.
By the time Geert reports the results, I may be broke, horror ending
for me!
Agree, but why and what cause Geert to act "unprofessional/emotional "?
This tweet from CEL-SCI Corporation and Geert is deleted:
"This is what FDA wants the data analysis to address, prospectively. We have experts doing it as FDA requires it. If you cannot wait,...bye. We will do it right."
What does it mean?
Not really, NWBO is showing the way if a company really wants
to go into the gray zone of SEC regulations, like I posted
here before, in many ways, NWBO and CVM have broken many
industry report PIII result protocol, IMO. One more warning
of risk April options, the biggest option open interests are
in April's now, if data is positive and Geert wants to, he can
delay the positive data PR to April 19, just like AMRN did in 2018,
to save the call writers if they are big CVM long funds, on the
other hand, if the big call writers are MM, Geert may PR the
positive data before the April 16, the short squeeze + MM covering
for naked calls sold may drive CVM up to much higher in short term,
IMO, I bet on PR before April 16, I also know that the risk is very
very high of missing the PR timing only if Geert really wants to screw
some one or save some one.
It is about my speculation of update on Mar 17 and deadline
of ASCO late-break Mar 18, notification of abstract Apr 2..
just wondering all the curious timing...
Hopeforthefuture3, thank you very much for letting CVM longs know
the added color of your conversation with Gavin.
Hopeforthefuture3, thanks for the confirmation from Gavin, at last
we have CVM's timeline of data PR by April 15(IMO) and normally
you give your self some spare time like two weeks, the count down
should start next Monday any day, but my guess is Monday, April 5th,
so I bought in again yesterday and finished my full positions today,
my base assumption of the results is P 0.05 or little better with HR
0.85 to 0.90, good enough for approval, good luck longs, this time
is for real!!! I bet there may be leaks, and if that is the case,
we may see CVM go up to $20+ right before the data PR day.
Yes, total CVM tuition is close $200K, lucky to net out a big gain
with Feb calls, CVM has been one of my longest losing bets but
ended up with huge gain by pure luck, any way, good luck to all
CVM longs, it has been a exciting CVM trip for last 6 month,
have to say Geert is one of a kind character CEO.
sab, I closed out all my Mar calls today..no more CVM play for me
now, NWBO's news today is telling me my guess street has priced in
all the good news of strong subgroup data supporting UK approval
, the question is FDA and EU approval "muddy" data pending, I think CVM is
in the same boat now with "OK" data but the upside should be limited
with 150% and down side is to $3 to $4, IMO. Good luck to CVM, I will move on
with my OMER position, same up side but much less risk with approval
due July, Bye! By the way, watch FED meeting PR tomorrow, interest rate
is the big elephant in the market, IMO.
You are very wrong, I have 750 March 25 to 40 calls cost at average
0.28, I do not hold my believe constant but change with what I see,
last 100 calls were bought on Thursday.
Filled Buy to Open 74 CVM Mar 19 2021 35.0 Call Limit 0.25 -- -- 11:39:25 03/11/21
Filled Buy to Open 8 CVM Mar 19 2021 35.0 Call Limit 0.24 -- -- 11:39:25 03/11/21
Filled Buy to Open 10 CVM Mar 19 2021 35.0 Call Limit 0.25 -- -- 11:39:25 03/11/21
Filled Buy to Open 8 CVM Mar 19 2021 35.0 Call Limit 0.24 -- -- 11:39:25 03/11/21
My target is "OK"(10% to 12% OS, P 0.05) data news next week. CVM may
trade up to 60.
I do not have a calculator, but I have paid a huge tuition to learn
from many many small biotech PIII trials with event delays not from
drug efficacy but from better SOC and better patient selections
that make the control arm patients live much longer than expected.
I have no solid reason for my concern of later reporting results
but my 30 years experience to rely on. There are reasons why CVM
and NWBO CEOs behave very different than all the rest of small
biotech CEOs in report PIII results, they are the only lawyer
small biotech CEOs I have seen, and they behave like a lawyer
but not like a small biotech CEO, they both think street may not
understand their PIII TLD which says a lot about their confidence
of the final results, IMO. By the way, the cheap Mar calls are
my last bet with CVM, if no data news next week, I am gone and
good luck to all CVM longs.
I think now the simple logical reason for the event delay is
MK trial selected and enrolled a very good number of patients
who lived longer, it is not very hard to do since SOC has 5 year OS
37%, if MK produces a homerun OS advantage 23+%, it does not need
3 month to analyze the whole data, now I think the best MK may produce
10% to 12% OS advantage, hopefully with clear biomarkers point to
which subset group patients benefitting the most, so CVM may have
pricing power after approval, if it take 4 or more month for data,
I am afraid MK trial fails the primary endpoint.
Thanks, but nothing new for CVM longs, we really like Geert to
provide some kind of time frame on data news.
You are more connected with CVM and chances of you are right
is very high, thanks for letting us know or better to Share
your estimates with us?
Thanks, good luck to all CVM longs...the last 2 lead to the first
two, I may be 100% wrong again, but worthy of a risky bet, IMO.
We can speculate what 4 facts mean: Geert pulling out conference, No Geert
tweets since Monday, and ASCO late-break abstract deadline is Mar 18th,
more than 3 month after data base lock...
Agree with your speculation, hence my MAR bet, but Unless Geert is lying
again, He says the data PR will be next day after he gets them.