the company started enrolling in september 2013. two through mid november isn't great but certainly a dire issue. remember, thoratec's competing trial got approval to start in january 2013 and still hasn't enrolled a patient as of the november update.
SRPT had really bad news. there's really nothing bad coming out of SSH.
the company started enrolling patients in september 2013. two patients by mid-november 2013. nothing concerning here.
we won't get the next update until ~mid feburary 2014 earnings call. well past the holiday period.
FDA apparently left the door open to reverse itself. oddly enough, it all depends on Merck.
negative for cholesterol lowering drugs that don't show true health benefit, like improved mortality. insurance companies now have even less incentive to pay for these..
"Mark Schoenebaum, an analyst with ISI Group, said the new heart-protection guidelines "appear to raise the bar for cholesterol-lowering drugs" that are not statins. He said use of Amgen's PCSK9 inhibitor, called AMG 145, if it is approved, could be slowed until data from the drug's outcomes trial arrives in late 2017 or early 2018."
"I read the new guidelines as a negative for any drugs that aren't statins, including PCSK9 inhibitors," said Jon LeCroy, an analyst with MKM Partners."
stock is in a downward channel, like many biotech/high beta healthcare stocks (alny, pcyc, regn etc). nothing concerning at all. will breakout of channel shortly.
i was going to say that 35% or lower EF as a cut-off for inclusion into the US trial doesn't seem unreasonable to me.
as for the use of medications during the trial, I am almost 100% sure that enrollees continue receiving medication and medical therapy. the Counter-HF trial is set up like every other cardiac trial (e.g. thoratec, heartware, abiomed etc) where the device is added on top of the medical therapy.
a better marker of mortality is....mortality. that's why these trials use hard endpoints and fda doesn't use LVEF. you're barking up the wrong tree here.
even giving you the benefit of the doubt on the outsized importance EF, the trial is a comparison to current medical therapy where there is zero benefit on EF, more likely a rapid deterioration and should experience even worse outcomes. by your own criteria, c-pulse should have an easy time beating the current standards.
second, we already know the trial is open for five years. enrollment completes in 2016 with a 12 month endpoint? why is this news?
for the the fda and cardiologists, EF has never been accepted as anything more than a weak surrogate endpoint.
even impella's PROTECT II trial used the hard endpoint of heart attack, death, hospitalization and not ejection fraction, even though it is only used for temporary support. it will sell about $160M this year.
hard clinical outcomes are what matter which is why the fda required such endpoints in sunshine heart's trial.
patient 2 was off c-pulse and EF essentially unchanged. how is that not recovered? patient 1 is now class I HF and patient 3 has reduced his usage of c-pulse by half. my point is you are looking at the wrong metric.
the trial end point is freedom from heart failure related hospitalization, lvad implantation, transplant or death. LVEF isn't even a secondary endpoint. the fact that patients are weaned or weaning themselves off c-pulse bodes very well for the trial success.
not sure what data you are looking but in one patient the LVEF was 45% and he also turned off his c pulse. another patient at 35% and reduced his usage by 1/2. st. luke's did an entire presentation on patients weaning themselves.
the data is on the TCT presentation. seekingalpha article has the link. 20% LVEF absolute improvement in early experience. no competitive treatment even comes close.
i suggest you do some research before posting. the EF are right on the TCT presentation. seeking alpha article has the link. the improvement is better than any drug or device has ever shown ( 20% in many cases).