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You are right, NWBO is trying to find subgroup data
with bio-markers to prove DCVax®-L works, I think
DCVax®-L PIII is really messed-up with the PSF
primary end point and high % cross-over from placebo
arm on secondary OS endpoint, IMO. NWBO is trying very hard
with FDA to write a new SAP, so far NWBO has not PR
any agreements with FDA yet, from DNDN's experiences,
NWBO is going to have a very hard time asking FDA approval
with any subgroup efficacy, I used to own 1.55M shares
of NWBO, when NWBO say they are going to write a new
SAP, I sold out, but watching on the side line to the
end for a good lesson.
My mistake, thinking 48%-52% OS advantage over
SOC, that is not what you mean. Any way HR under
0.70 is a grand slam win, IMO.
25% OS advantage is a blockbuster homerun, and 48%-52% SOC OS
is a grand slam, may be too good to be true, guarantee CVM going
over $100+ the day topline PR, IMO.
Unfortunately, my suspicion of 42 month time mark
PFS cross over down come true to the worst outcome,
which means Thermodox arm patients has same or more
PFS patients after 42 month in the trial and no fat
OS KM tail to drive up efficacy, hence this look has
to stop the trial. I escaped second time, CLSN's
offering action and words in the last PR did give
me a hint.
Agree, I am 100% topline by July 27, there is a good chance
any day from July 13, IMO. I am going to stick to my view of
once the data base is locked and unblinded, the primary OS
end point and 3 secondary endpoints data are out in minutes,
OS primary endpoint P value is less than 0.05, success, above
0.05, failure, no data analysis can change the outcome, so
topline PR should be out in days when CRO has the OS data,
full data set can be presented at a cancer conference, IMO.
It is my fault to replay to you, for your information,
I have been betting on PIII trial result plays for 30 years.
BY the way, I am long CVM for positive outcome, good bye.
Once the data base is unblinded, the primary OS
endpoint data is out in minutes, it is SS or not,
rest of data analysis is data mining, after the topline
data is in CVM hands, CVM may PR after 3 days, if more
than 4 days, be cautious, IMO.
CVM has two CROs, so data lock should be sooner than
one CRO, if CVM has only one CRO, we can expect close
to 3 months data clean and scrubs to lock the data base,
my read is data base lock is very close, IMO.
His words are "data lock and analysis", May be he
is casual about what is saying, if data base is not
locked or ready to be locked in days, there is no
data to be in analysis stage, IMO.
I am all out of CLSN again, I am fine to take profits of
$4/share even if I miss out if second look is a success, I
read the offering and today's PR as CLSN is more guarded
about second look chances of stop, good luck longs.
The risk is still here, I was focusing on worst case
before, the science is very sound and the subgroup data of
285 patients with clear cut of 45+ min RFA + OS endpoint
is also very compelling, I do have a plan to hedge saftly
this time, I bought double number shares Friday and Monday
right after earning's CC, and sold half today, got the rest
free for the second look results now, CLSN is going up early
and fast than I thought, expecting CLSN at 3.50 to 3.80
by end of June, if street smells a stop for efficacy, we
may see 4.5 to 5 right before topline PR on week of July
6, IMO.
I bought back, if OPTIMA is close to subgroup
data, second look has to stop for efficacy. The
OPTIMA 42 month blended PFS cross down below
the subgroup's PFS KM curve is telling me the
OPTIMA final 197 event OS curves are very narrow
or wild open at the tail end, it means if wild open,
OPTIMA is performing better than the subgroup and
efficacy should shown up at second look, IMO.
If game is fixed, generics will not settle, looking back from the AMRN stock actions, it sure looks like someone knows the plan, IMO.
I go with "something more sinister", I always think AMRN has to be
at a US BP's hands for national interests, a buyout price $20B, guess
AMNR may be really asking $30+B, and today's decision is the way FDA+BP
pay back to AMRN not playing with the US unspoken rules, IMO.
So true: "Never pays to be Behind The Upcoming Curve"
American Bread & Circus (Hidden Secrets Of Money Ep 10)
A) 50 B) No buyout
Agree, my #1 pick to buy AMRN has always be PFE, and AMRN
can only be bought at an US BP's hands to collect the tens
of billions US revenue, IMO.
The following quotation is commonly attributed to Albert Einstein:
"Two things are infinite: the universe and human stupidity, and I'm not sure about the universe."
you are part right, but I donot know about "The leaders of China
and Russia are not master minds. They are just as stupid and short
sighted as our leaders.", the US, China and Russia leaders are not
stupid, have any one thinking about why this is happening now that
US debt is so high and Hedge funds are trillions in leverage and companies
are trillions in debt to buy back their own stocks, MAX has reached,
only the way is down, who is going to pay for the loss? This is the only
way out for 1%....
Privatizing Profits And Socializing Losses
https://www.zerohedge.com/markets/privatizing-profits-and-socializing-losses
With the news of FED buying company's debt, one major
concern of $billions debt needed to buy AMRN is removed, IMO.
This problem is the real cause for entire world in a lockdown:
The World Is Hit With A $12 Trillion Dollar Margin Call
"there is now - in JPMorgan's calculations - a global dollar short that has doubled since the financial crisis and was $12 trillion as of this moment, some 60% of US GDP."
https://www.zerohedge.com/markets/pray-powell-world-hit-12-trillion-dollar-margin-call
Totally 100% agree with your and HDGabor's view,
BO or partnership in EU in Q2, I bought 1000 June
calls for BO by PFE at $50-$55, $21-$22B deal.
Real time futures....DOW down 948, SPX 95....
https://finviz.com/futures.ashx
This is what AMRN needs to do .....marketing cost...
AbbVie, Lilly, Pfizer lead pharma TV spending to roaring start in 2020
"Pharma TV ad spending has started with a bang in 2020. Collectively topping $200 million, the biggest 10 TV time buyers spent more than $15 million each, with No. 1 Humira doling out more than $40 million in the first 30 days of the new year, according to data from real-time TV ad tracker iSpot.tv.
Yet while AbbVie TV ads for Humira held a commanding lead, three other drugs spent more than $20 million for the month: Eli Lilly’s diabetes medicine Trulicity, Pfizer and Bristol Myers Squibb anticoagulant Eliquis and another AbbVie drug—newer psoriasis fighter Skyrizi—which came in fourth place at $20.5 million."
https://www.fiercepharma.com/marketing/pharma-tv-spending-off-to-roaring-start-2020-led-by-abbvie-lilly-and-pfizer?mkt_tok=eyJpIjoiWkdZeFpXTmhNRE01TkdZMiIsInQiOiJ0bFp1dXg1R1lURGhaeXdKMlU4ZVgyY1wvcW1sYWhRMEJRMzF4a21tc2V0czlobjVhQnRpQ1lNMTZ4NzI0ZjZMSHBoeFVsZlZMZnNkaFYrUWpGWCtqWWVjZ3BBRXFPWkp4Q0tDVnhOK2FvcHEwSWJhMjFZMk8xUTI5OXZuSWVDNVQifQ%3D%3D&mrkid=47116683
Do not forget to "payoff" hundreds of thousands frontline Drs
RX to patients which may cost hundreds of $millions/year, the
last time see somewhere, PFE+BMY spends close $400M/year for
Eliquis marketing or "payoff".
You need muscles with insurance companies and big money for
marketing, and AMRN does not have both, look at PTLA total failure
to launch and ACAD slow launch for examples. CVD and Neurologic
Diseases are not for small biotech companies, these are BP's
territory, AMRN better puts up for auction after court win, IMO.
Great, please post after you get any answer for your questions.
I am going to listen to next CC, think CEO is back into the wall,
there is no more room for him to talk up CLSN stock without solid
new information, IMO.
No, the graph is showing the real time PFS data collected
at most recent month, last NOV or DEC? There is not much
down side risk here at 1.35 until GEN-1 data, if not stopped
at second look, CLSN may test $1, IMO. I like SAVA much
better risk/reward than CLSN now, I think 60% chance OPTIMA
continue to the final look, IMO. Now I get it why CEO keeps
telling us interim look HR numbers but not P value, he is
trying to keep the stock above $1.5 to sell about 1M shares
each Q, the fact is the P value is the one to decide interim
look to stop or continue, can not blame him by doing so to
fight CLSN survival, but not honest to individual investors
like us, IMO.
Next CC in Mar should be more interesting...analysts should ask
CEO to explain the PFS KM curves tail....
No, it means at month 42, there are more patients having
the HCC coming back and the 5 year OS may go lower too.
Here is the CLSN new presentation from Jan 28, 2020:
http://investor.celsion.com/static-files/70e45734-e80b-41dd-b6af-e19f435f46c0
On page 18: OPTIMA Study: Blinded PFS Data Consolidated for Both Arms
my consern is HEAT subgroup gets the P value down to 0.02 from OS
wide separation tail of the KM curve, and OPTIMA PFS crossed down
below subgroup PFS at 42 month time mark, and Subgroup flat at 27%
on 38 month time mark vs OPTIMA falt at 18% on 46 month time mark,
raise concern OPTIMA OS tail may not be as good as the subgroup that
affects P value at second look, IMO.
Kiwi, I think SAVA has gotten feed back from KOL last DEC
that PTI-125 may be a breakthrough drug for Alzheimer, so
I followed the insiders and bought my full positon, SAVA
is a very high reward/limit risk biotech, 90+% PIIb may
repeat results of PIIa, risk of placbo effects on biomark
endpoints is very low, IMO.
I sold out my full position again, not so sure
second look can stop the OPTIMA because CLSN
posted the new HEAT subgroup and blinded OPTIMA PFS
data, OPTIMA PFS curve has went down below the subgroup
PFS curve at 42 month time mark, which may mean the
OPTIMA 5 year OS data may not be as good as the subgroup
data and P value may not hit the target of less than 0.02
to stop at second look, fair chance OPTIMA may win at the
final look next year, IMO.
It is eazy and cheap to run a double-blinded PII
trial with 100 patients with biomarkers as primary
endpoint to prove V works on Alzheimers, check out
SAVA, 13 patient PIIa with outstanding data, and
PIIb double-blinded data is coming in Q2....
I do not know, but I have to respect DewDiligence opinions
regarding potential peak sales, He is 100% right few year's
ago on PTLA's Bevyxxa and Andexxa sales estimates, very small
chance of success to gain market shares from big pharms in
CVD.
Ask GILD and BIIB, it is not eazy to replace 10+B revenue loss,
so far, ABBV has spent more than $100B to replace HUMIRA's $20B
loss in mid of 2020s. By mid of 2020s, street will heavy discount
AMRN's stock to what ever V's total profits to net cash value,
BIIB and GILD are valued at next 10 year's net profits now,
and finally I understand why AMRN is trading around 20, street
has priced in V's next 10 year's net profits with peak sales at
$3B, it is AMRN's job to prove street is wrong, IMO.
AMRN will open trading today after approval PR because
today is Friday, weekly options expire at close.
Here is the HEAT subgroup data timeline I get from CLSN website:
May 20, 2012: HEAT enrollment completed.
Jan 31, 2013: HEAT results.
May 17, 2013: First time, subgroup data HR=0.65, P=0.105
Sept 16, 2013: subgroup data HR=0.623, P=0.058
Jan 27, 2014: subgroup data HR=0.64, P=0.0495
Dec 30, 2014: subgroup data HR=0.65, P=0.037
July 15, 2015: final subgroup data HR=0.65, P=0.02
It is very clear to me OPTIMA final HR is set which
means success or failure known to DMC, only P value
may change, if Theromodox is working as expected like
HEAT subgroup data has shown, P value may go lower to
increase the level of SS.
"AMRN still has 'tute ownership of around 50%", this the eye sore
in the street's eyes, It really looks bad on them that hundeds or
thousands inidividual investors are AMRN millionaires, so street
want to shake out as many shares as possible before giving AMRN
a fair value, IMO. Thanks to many, especially to JL, diehard AMRN
believers are not selling.
I was looking for some thing close to this for the first interim look:
"Tecentriq in combination with Avastin reduced the risk of death (OS) by 42% (hazard ratio [HR]=0.58; 95% CI: 0.42-0.79; p=0.0006) "
Well, I guess OPTIMA does not out perform the HEAT subgroup
data, and the best we can see HR =0.65 to 0.7 with the second
interim look. If second look stop for efficacy, I expect CLSN
to partner for Asian market or buyout. I bought my full position
back. One thing is for sure, what ever the first look HR is,
it will be the second look and final HR, only thing may change
is the P value, more the events, lower the P value.
https://www.businesswire.com/news/home/20191122005376/en
https://www.fiercepharma.com/marketing/roche-aims-for-bayer-s-liver-cancer-share-tecentriq-avastin-survival-win?mkt_tok=eyJpIjoiWldKak56Y3hNR05pTnpKaCIsInQiOiJYSStoeWR0MW83Rk5hbTAzQ2xvQ2M0NVVGVjNCcmF3TkREUDJTbXdIN1Blcm5lVkhOQUN1aWxoc2RjdXFcLzU1TEZnTlcxWnpaZmRBVkZ3eWxWeUlcL2FxRkNzSGZlSldBempUYnFrc0Y5MTEwb25PSzByUjlnZkpzcVk3UzIxVkhWIn0%3D&mrkid=47116683