I think the comment was intended to show respect to Sudhir, with a dose oh humility thrown in. That aside, this is a terrific team assembled that's coupled with cutting edge science. Awesome combo.
I could understand the FDA's reluctance if etep posed a potential serious health risk to a wide portion of the population, but in this case there is a finite % of the population that can directly and immediately benefit from this drug. There is no current alternative that poses no adverse side effects and that can be safely administered. The only logical conclusion why the FDA is stonewalling must be tied to something far more sinister, and longs all know what that is.
That is the part of this butchered equation that is so difficult to comprehend.
These "public servants" are so out of touch with reality and think the citizens report to them. Nonsense.
It is well past time to dismantle this agency, or at the very least instill strict oversight. Too much autonomy is a very bad thing and Congress needs to call their bluff. Congress and the FDA need to do their jobs. Period.
The parents and advocates need to do the following:
Schedule a public demonstration in Washington and notify the media. And what will draw attention to yet another demonstration? By having the kids waiting for treatment parked in their wheelchairs on the sidelines cheering on the kids receiving treatment as these kids engage in a game of touch football. Let the FDA then squirm and explain how they're still not sure dystrophin is being produced in these boys.
I've posted this before but it bears repeating. Sums up what / who we are up against............................
You're sitting at home one day and you realize your house is on fire. So you pick up the phone.
"Hello, Fire Dept of America (FDA), J. Woodcock speaking on a recorded line, how may I help you?"
"Uh, yes my house is on fire and I need you guys to come over and put out the fire."
"Well, yes, we'd love to, but can you assure us the house will actually burn down if we don't respond?"
"Yes, I'm positive it will if you don't come over right now!"
"Okay, please don't get upset with me. Let me run it past our crack team here. I'm sure we will be able to get something done, but even though I can make a decision, I will need to make sure the entire team is on board with the decision to assist you. In the meantime, could you please forward information on what materials were used to construct the house, how old the house is, any comparative houses like yours in the neighborhood that experienced similar fires, and oh, throw in some information on houses that haven't burned so we may be able to make the correct decision. And as soon as you get the info assembled we will call you in to review the paperwork and make sure everything is in proper order. And thanks for calling the Fire Dept of America. Have a nice day."
Dramatic action is what is called for. These parents and their long-suffering boys have been kicked in the gut and now need to make a statement that this type of behavior is not going to be tolerated any longer. You can't negotiate with unreasonable people. Expecting the FDA to do the right thing is like the definition of insanity, which is doing the same thing over and over but expecting a different result.
While I think it is unreasonable to hold CG completely accountable for this latest stiff-arm by the FDA, he is nonetheless the CEO and with leadership comes consequences. His responsibility is to MAXIMIZE the value of the company, and in that endeavor he has failed miserably. We don't really know what has gone on behind closed doors in the meetings with the FDA, but clearly there must be some friction.
And when the ebola situation is brought into the equation, well, something just isn't right.
I've tried to give CG the benefit of the doubt over the years, but at some point a decision must be made. Is this guy capable of getting the ball over the goal line? And as much as I dislike having to agree with others on this board calling for his dismissal or resignation, I think it is time to do so, for in mid 2015, at this point, there is much likelihood the FDA or the company will pull some other stunt that will result in additional delay. CG probably feels like Charlie Brown did when Lucy would yank the football at the last minute. Experience matters, and in this case, the company needs to get someone in there who has completed deals with the FDA, someone who has the industry respect necessary to finalize things. And don't feel too sorry for CG - his 2013 compensation with salary and options and benefits was just under $10 million.
And as bad as longs feel today, imagine how the poor kids and parents must feel knowing the FDA is treating them like #$%$, using them as pawns in whatever game is being played. Sickening.
Since you own that many shares (not) you must be aware (not) of all the SEC regs regarding insider trading being super careful about passing along info that could get you in serious trouble. Back to ignore dufus.
And don't for a moment think an infected individual won't try anything to get to this country. With our apparent "open border policy" and no restrictions on flights this has the potential to be very, very bad.
Kampala (AFP) - A hospital technician has died of the Ebola-like Marburg virus in Kampala, the Ugandan government announced on Sunday.
This is getting pretty serious. As long as our borders remain open, flights are allowed into the US, and our healthcare system remains "free", it's reasonable to assume there will be many more Ebola cases showing up in this country, among other illnesses. Those that have the means to get to this country and are infected will make every attempt possible to get here.
Is it possible this patient has a different strain? Is it possible our government is completely incompetent? Why does it seem SRPT is the girl at the dance nobody wants to tango with? I don't get it.
Just saw this on twitter. Someone may have already posted so if this is old, my apologies................
ALEXANDRIA, Va., Sept. 25 -- Sarepta Therapeutics, Corvallis, Oregon, has been assigned a patent (8,835,402) developed by two co-inventors for a compound and method "for treating myotonic dystrophy." The co-inventors are Ryszard Kole, Corvallis, Oregon, and Gunnar J. Hanson, Bothell, Washington.
The patent application was filed on Sept. 26, 2013 (14/038,314). The full-text of the patent can be found at http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=8835402.PN.&OS=PN/8835402&RS=PN/8835402
Pay very close attention to the names these clowns use. Always a very subtle change of lettering in their user name. In this case is it now starTe11 rather than the usually relentless starFe11.