The way I see it:
Here is what I speculate: The IS trial has 6 trial sites in UK and two in Glasgow, so
ESO 2015 committee may have a good idea how the results are and want ATHX
to present it, ESCO 2015 committee breaks the later-abstract rules to allow
ATHX to present the data under the condition no PR is issued before the presentation
because ATHX can not meet the later-break deadline(open Feb12, close Mar 3).
Agree, but ATHX PII trial cohost1 6:2 and cohost2 6:2, I think DMC can guess with
confidence how Multistem performed with those 12 compare to 4 patients in the control
arm, nothing is for sure until the final data reveals, IMO.
No, the PR is for the topline results without data, like primary end point
is or is not statistically significant, tonight or tomorrow morning, IMO.
It is not over yet, if the results are SS, ATHX may issue a PR
Thursday or Friday to just say the trial has met the primary end
point and details to be presented on April 19th, you never know.
If my best case happens(P =0.01 or better), it means the results is highly
SS, Japan AA is possible if ATHX apply, FDA's BTD is a sure thing, $20 is
the minimum, only $1.6B market cap for a drug has billions peak sales potential
and 80% PIII success. ICPT NASH trial is about to start PIII and is worth 6B.
If the primary P value is less than 0.01 or better, we may see a ICPT kind of reaction,
Can we trust ATHX CEO's comments about the first two group's results translate into
the big group 3?
The IMPRESS SPA analysis plan is Log-rank analysis, expressed in Reduction of risk
in HR, they are the same thing.
Watch PBS Cancer: The Emperor of All Maladies, you may see
Dr Steven A Rosenberg is running PI/PII trials for solid tumors.
In the show, Dr Steven revealed very good results of CR in melanoma
and brain cancer, for one group 6 melanoma patients, Dr Steven says
4 patients have CR(cured??) and 2 PR, one brain female patient is CR
(cure??). I think KITE and Dr Steven may present those early results at ASCO's
late-breaking sessions, IMO.
99% the second look news come out any day now, there is no way NLNK is
going into conference with out the results out by next Monday, my guess is
trial to continue and the stock has limited down side, IMO.
I agree RCPT is not looking for a sale, but PCYC buyout and the payout
ratio teaches big pharmas to buy out RCPT as a better option. JNJ pays billions
for upfront payment+royalties+milestones, and only gets 1/2 the drug but
only 1/3 net profits after all the cost to JNJ. Now the question is how much
RCPT is willing to sale, $10B gets RCPT to talk, PCYC valuation set the par
on RCPT buyout price.
Nomura analyst M. Ian Somaiya commented, "Our Buy rating is based on our view that eravacycline could be a best-in-class antibiotic for the treatment of complicated urinary tract infection (cUTI) and complicated intra-abdominal infection (cIAI), generating peak sales of $1.6bn. This is based on data that demonstrated broader coverage versus legacy and recently launched antibiotics. Combined with its oral step-down option, eravacycline would enable cUTI patients to begin treatment at the hospital (IV dose) and complete it at home (oral dose), which should lead to shorter hospital stays and more rapid adoption. TTPH in our view also carries lower relative clinical and regulatory risk given the release of positive top-line results from Phase III IGNITE 1 in cIAI and lead-in portion of the Phase III IGNITE 2 cUTI trial. We expect presentation of detailed data from these trials in 2015 (page 11) to support continued upside. However, the greatest potential source of upside is the passage of the DISARM Act, which could support higher pricing and the faster adoption rate of drugs approved after January 1, 2015."
At very very conservative buyout of 3 times peak sales will be 4.8B, so far I have seen analysts peak sales
from $1b to $1.6, using mid of the range is $1.3B, 3 times 1.3 is $3.9, low end is $3B.
IF we agree BIIB has the best data so far, compare to what LLY has gained
$37B from its positive subset data, BIIB has some upside to catch up, IMO.
The results clearly show BIIB037 is a very effective drug against AD,
the safety is a concern, and hopefully manageable. BIIB gets another
megabillion drug on the way. TYSABRI may cause death for very few
patients, but the risk/reward is worth for patients to demand for FDA
to put it back on market few years ago. Since the ARIA-E goes away
in 4 weeksby stopping the treatments, BIIB may manage the risk by lowing the dose to 6mg,
a drug holiday for 4 weeks, new ways to identify AD patients early
to put on 3mg BIIB037 to prevent the build up of the amyloids(I think
this last point is a good answer) which makes BIIB037 potential sales
even bigger than $10+b many are saying now IMO.
LLY release PIII AD results on Aug 24 with positve results for subset
mild patients, LLY was trading at 42, now at 76, 81% gain or 36B
market cap. LLY 2012 sales 23B+earnings $4.32, 2015 estimate sales
20B+earnings $3.16, no major drugs waiting approval, so I assume
most of the $36B gain is from the positive AD results. BIIB has the
best AD results so far that all agrees, so adding $47B market cap($200
stock gain)to BIIB start from Dec 2nd the first PR about positive PI results
which is about 308+200=$508, that is most of the price target analysts
raise to today, that is fair price in weeks, IMO.
CEMP did ouptform TTPH since CEMP earnings CC,
and after last two presentations, CEMP added about
$8 to the stock.
I think comparing BIIB to BMY is not good one.
Here is the numbers:
Trailing P/E (ttm, intraday): 56.47
Forward P/E (fye Dec 31, 2016)1: 29.72
PEG Ratio (5 yr expected)1: 2.45
EBITDA (ttm)6: 3.92B
Net Income Avl to Common (ttm): 2.00B
Trailing P/E (ttm, intraday): 38.48
Forward P/E (fye Dec 31, 2016)1: 23.89
PEG Ratio (5 yr expected)1: 1.42
EBITDA (ttm)6: 4.60B
Net Income Avl to Common (ttm): 2.93B
BIIB beats BMY in all the important measures of growth and profits,
if market uses those BMY measures to value BIIB, BIIB may be close
$600/share. All is relative, SP 500 is trading at 18X2015 earnings estimate
of 3 to 4% growth, 10 year bonds get 2%, savings get 0.25%.
Why you do not compare to REGN with similar growth trading at
11.5 time of 2016 sales? By the way, it is $10B today, next week
BIIB may gain another $10B, but nothing wrong taking profits.
Hope so too, they may be waiting for PIII results to settle the buyout
price. It is the best for the buyer to pay a fair price and to take control
of the NDA. It is a too big a task for a small company like TTPH
to scale up manufacturing for tens of millions dose to pass Q&A
with FDA, SRPT and ACAD say no problem to scale up, a simple
process, look at the results, has taken them two or more years to
scale up, in ACAD case, still going to year 3.