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?
CEO does not want to sell the company, if Hyperacute PC works and he does believe,
NLNK is...I do not want to be called a pumper, I will just leave it here.
some good news, likely 1st look stop, I do not why
some institutions are buying at ask day after day.
Any way, my target 50 to 55 is reached early than I think,
so here it is my quess, 1st look stop and follow the big
If the peak sales is $6B, your 50 price is too conservative,
we may see 50 event by end of April before the interim
depending how strong the results and the "leaks". From my
experiences, most of the biotechs with blockbuster potential
drug PII data coming, market expecting postive, have $1+B
martket caps before the results because institutions demand.
We are talking about OHRP in the League of VRUS and ICPT,
multi Billion sales potential here. By the way, do you know how
long the patents protection are? I can find them in OHRP's SEC
Roche or REGN have the most to lose, so they are the ones to
start the talk, PFE and GSK may join to bid, VRUS all over again,
for the right price, OHRP may take the offer, JMO.
I have a feeling we may see a repeat action of last OCT.
Last OCT, Jen was telling us Etep works, but wallstreet
doubt her, this time the right KOL told FDA Etep works
and Wallstreet says no way, we will see who is right.
The FDA is approving Northera under the accelerated approval program, which allows for approval of a drug to treat a serious disease based on clinical data showing that the drug has an effect on an intermediate clinical measure (in this case, short-term relief of dizziness) that is reasonably likely to predict the outcome of ultimate interest (relief of dizziness during chronic treatment). This program provides patient access to promising drugs while the company conducts post-approval clinical trials to verify the drug's clinical benefit, which for this approval is a long-term effect on patient symptoms in NOH, a chronic disease.
A panel of agency advisers voted overwhelmingly last month to recommend Northera’s approval. FDA staff members had expressed concern that Chelsea hadn’t proved the drug works longer than a week while advisers pushed for flexibility because no other treatments exist for the condition.
“People with neurogenic orthostatic hypotension are often severely limited in their ability to perform routine daily activities that require walking or standing,” Norman Stockbridge, director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research, said in the statement. “There are limited treatment options for people with NOH and we are committed to helping make safe and effective treatments available.”
FDA, what about Etep and DMD?
If true, FDA may want a long meeting to settle all the
issues of AA and PIII trial, instead 90 minutes, the meeting
may last up to 8 hours long, can only happen on a holiday,
any way, Friday's trading may tell us something, IMO.
The 9 month treatment for the 60 patients end in April 7th,
may take few short weeks to get the data, so any time near
the end of April is reasonable time to start to expect the interim