Yes, the control MOS may be estimated 22 or 23 for the first look,
but when more events come from patients of the second half 361
enrolled starting from July 2013, I think the control MOS may go down
to 20 or 21 which will be final control MOS, 181+ events from control
arm is near certainty, the treatment arm may go from 29 to 31 at first look
up to estimated 35+ at second look, P value less than 0.001, JMO.
and its trial events is later too, the results may tell us how much the SOC
has improved for metastatic pancreatic cancer patients:
Study of MM-398 With or Without 5-Fluorouracil and Leucovorin, Versus 5-Fluorouracil and Leucovorin in Patients With Metastatic Pancreatic Cancer (NAPOLI 1)
I am waiting for a 3+M trading day to indicate the meeting is
happening on that day, there is small chance FDA may surprise
and issue a pre-meeting minute to SRPT about FDA's decisions
and the meeting is to go through the points, IMO.
Only new information I can see from earnings report today is
NLNK has done the ATM for $60M, with stock options excised,
we may see share outstanding close to 29M now.
The reason I say no CC is if there is CC for earnings report, NLNK
may issue a PR about a week in advance to let analyts have time
ready to particitate.
Where do you get the information NLNK is going to
release earnings report next Tuesday? If it is true,
we may not get a CC, just the earnings report, we may have
to read Q4 SEC filing to get any new information about the trial.
I also believe what you are saying, HyperAcute PC may improve 5 year survival
rate from 10% to 30 to 35%. It is a shame Provenge does not have the chance
to show its true effects, if DNDN run a long term trial Provenge vs XTANDI,
Provenge may beat XTANDI by a big margin at 5 year survival rate too.
The events are coming from patients in the trial less than 24 month
and the curves for patients in the trail more than 28 month are flatting
now, I assume most of the next 100 events may come from patients
in the trial from 12 to 24 month group too.
What is the difference this and last year's ASCO about NLNK's IDO?
IDO was hot at last year's ASCO, but NLNK got nothing in stock action,
Does NLNK has new data to present at this year's ASCO? Not I can find.
The two things positive we have to see are insiders stop selling,
big institutions are adding their positions and new institutions
are buying in Q2 and Q3 to indicate second look a success,
as long as I see insiders and institutions are connected by inside
information some how, JMO.
Besides all the models and projections, we ignore two warnings
of relentless insiders selling and FMR reduced holdings from 1.95M
to 1.34M + RA sold out 1.85M position last Q, we have to be very conservative
now about the second look, I will have to look at how the stock trades
when the second look is close to see the chance of second look because
someone will know the results before the news, just like what has happened
last few days.
Agree, my view is from the belief of HyperAcute works. Now only thing
left for us longs is 300ml and 12 month treatments making the difference.
Yes, if you are negative about HyperAcute PC, one thing is for sure the SOC
is much better now, and NLNK trial assumptions of control arm is way off the
mark, which is reasonable to question PII data now.
cancer trial results are very unreliable, especially cancer immuno-drugs
because the delay effects, continue means the initial effects are weak but
the tail may be very strong, JMO. One thing I do not like is NLNK should
let us now when the 222nd events occurred, it is real unfair to us individual
investors that wallstreet has known the date by leaks, and the worst part
is results are leaked too, that is why the $8 dive in one day.
One thing is for sure, if 1st look is to continue, the control arm patients
are living longer than we estimated 19 to 21 and the curve is separating
late, I estimate at 10 to 12 month mark because all the responders KM
show the curve converge at 12 month mark, 70% survival rate, I may be
very wrong, but that is how I look at.
ISIS and ALNY is worth $5.5+B, SPRT is worth $1B,
I do not think SRPT PII data is less convincing than
any of ISIS and ALNY PII trials' data, and SRPT can beat
ISIS potential platform peak sales any day.
I agree, Any fools read into CC negatively, FDA is considering SRPT filing AA now
and when FDA says to file for AA, it is a done deal AA by end of the year. We may
see SRPT traded up to 38 to 40 before the news, JMO.
If FDA says start the PIII with 60 patients no placebo arm, do a muscle biopsy for
dystrophin at 24 weeks, and apply for AA if positive, keep the PIII going for two year
for 6MWK end point final final full approval?