Status of NPSP Gattex for crohns disease out of core focus and only on partnered basis ?
why ? not so confident ?
NPSP is not ALXN or BMRN, two drugs cant get them $600M let alone talking about billions in revenue.
Company is having hard time. Gattex they have only 303 patients
2014 they are going to have between 305 to 315
why so much enthusiasm
where is patenright1 the boards number 1 chronic liar,,suffering from analhemorrhoids
if only Senator Rand Paul issues a press release SRPT will take a 50% hit..... I would love to see him just say that he is onto SRPT
Markets falling apart -- SELL First and think later -- Going back to $20
Will CLDX see $22 or $20 in the coming days...Market falling apart
PGNX repeating VICL story , weeehaaaaaaaa , premarket ASK at $4
SRPT trying to scam FDA and tax payers ??????????
FDA knows SRPT management is trying to spin lies and make quick money ....
shareholder class actions, announces the filing of the first securities class action lawsuit against Sarepta Therapeutics, Inc. ("Sarepta"), as filed in the United States District Court for the District of Massachusetts. The complaint alleges violations of federal securities laws; more specifically, Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5, including allegations of issuing a series of materially false or misleading statements surrounding its disease-modifying drug, eteplirsen, which is used in the treatment of Duchenne muscular dystrophy or DMD. These statements had the effect of artificially inflating the market price of Sarepta's stock during the period of July 24, 2013 through and including November 12, 2013 (the "Class Period").
During this Class Period, it is alleged that Sarepta issued a series of multiple statements concerning, among other things: (1) the prospects of the Food and Drug Administration's ("FDA") acceptance for consideration of a New Drug Application ("NDA") for eteplirsen based on Sarepta's Phase IIb study data set, and (2) the significance of that data set. However, during a meeting on November 12, 2013, the FDA informed Sarepta that its announced, anticipated NDA filing for eteplirsen was premature. On this negative news, Sarepta's stock price fell $23.40, a decline of 64%, from its closing price of $36.56 per share on November 11, 2013, to $13.16 per share on November 12, 2013, on extraordinary volume
exactly, the same story is being circulated by RNA liars, both are liars trying to scam a failed drug into money making
Recently, Prosensa has reported the initial findings from the further clinical data analyses of drisapersen across all studies. These findings suggest that treating earlier in the disease and treating longer shows a delay in the progression of the disease.The subset analyses focus on outcomes in DMD boys seven years or younger and those over seven years old as measured by the six-minute walk test (6MWT). In all studies, a treatment difference was seen in the younger patient population. Notably, the preliminary analysis of the 96 week extension data from those participating in the phase III DMD114044 study shows a 49 meter difference between those on continual treatment (n=52) and those who had been on placebo for 48 weeks followed by active drug (n=31). Those previously participating in the DMD114117 study showed a 52 meter difference at 96 weeks (n=13, n=17, respectively). Key safety findings are consistent with previous observations, including injection site reactions, proteinuria and mild to severe thrombocytopenia. Prosensa is continuing to evaluate the results in the context of the overall clinical program in addition to performing additional analyses to fully understand the results of the study. Until this additional work is complete, dosing of drisapersen will continue to be held within ongoing studies.
A Phase III placebo-controlled study of drisapersen in 186 DMD patients (DMD114044 or DEMAND III) at 47 sites in 20 countries has been completed. This study has not shown a statistically significant or clinically meaningful treatment difference (10.3 meters; p=0.42) in its primary endpoint, which was the 6MWD between the placebo group and the continuous active-treatment group at a dose of 6mg/kg/weekafter 48 weeks. There were no statistically significant or clinically meaningful treatment differences between drisapersen and placebo on the majority of secondary endpoints. A pre-planned subgroup ≤ 7 years showed a non-statistically significant but potentially clinically meaningful treatment difference of 21 meter and a statistically significant (p
A Phase II placebo-controlled study of drisapersen in 53 DMD patients (DMD114117 or DEMAND II) has been completed and has demonstrated a statistically significant and clinically meaningful difference in its primary endpoint, which was the distance walked in the six minute walk test (6MWD), between the placebo group and the continuous active-treatment group at a dose of 6 mg/kg/week after 24 weeks (35 meters; p=0.014). This clinically meaningful treatment benefit was maintained after 48 weeks of treatment (36 meters; p=0.051), and drisapersen was well tolerated throughout the duration of this study.
A Phase II placebo-controlled study of drisapersen in 51 DMD patients (DMD114876 or DEMAND V) at US sites only has been completed. This study compared 6mg/kg /week with 3mg/kg/week and placebo and was not statistically powered to show a significant difference between the arms. The study has demonstrated a clinically meaningful (but not statistically significant) treatment benefit of 6mg/kg/week of continuous treatment over placebo (27 meters; p=0.069) in 6MWD at the primary endpoint at 24 weeks.
can you please stop spinning. let us read what RNA says instead of your spin because you hold the shares of SRPT
The overall drisapersen clinical program comprises three double-blind, placebo-controlled studies (DMD114117, DMD114876 and DMD114044) and two long term open-label extension studies (DMD114673 and DMD114349). To date, over 300 patients have participated in clinical studies of drisapersen at more than 50 trial sites in 25 countries, and patient retention rates through March 2013 averaged 96% across all drisapersen clinical studies.
Drisapersen has successfully completed a twelve patient Phase I/II clinical trial. Subcutaneous administration of the drug for a period of 5 weeks showed that the drug was well tolerated and that dystrophin expression was restored in all 12 treated patients. The open label extension of this study is on-going and the patients have been receiving the drug for more than 188 weeks, in which the majority have stabilized in their walking ability.
excuse me for interjecting... 12 week 6mwt on how many patients 1 or 2 or 6 or 12 ?
small group = trial and error
i am sure even if you don't give them anything and make them walk they would have...
more here: http://www.businessinsider.com/lingerie-model-photoshoot-techniques-2014-1
I agree with you, michael fuller has an old habit of posting under various IDs include Jonzkelllysockingyourballs and I think Gene= Patenright1 = michael fuller
as for Gary / Pharmaman i thought he is in prison for insider news regarding QCOR, is it out from prison ?
Give me more red ratings....I am happy this red ratings and SRPT to be down 10% today
Going to be down 10% and sell stops margin calls by those who bought at $29
i say below $26 AF just made foolish comments