There are only 2 PERSPECTIVES HERE right?
THE BOYS AND THEIR FAMILIES: Did this FDA action help them get this miracle drug to market FASTER so it can save MORE of them and MORE quality of their lives? I don't see how it made it FASTER, but I know some of you out there will make this case...
WE THE SHAREHOLDERS: Is this FDA action GOOD FOR US? In this game; we keep score with $$$$; and at the end of today; I want you to argue that you are better off than you were yesterday on a $$$$ scorecard.
I LOVE ETEPLIRSEN and the great promise it holds for the kids and their families AND I still love SRPT and the long term promise it holds for us financially (and what it has already done); but TODAY, I am entitled to a "lover's quarrel" with SRPT management.
King Bud, I think you should stick to your ABC's. This is a very fundamental issue. Thats right...say it slowly....FUNDAMENTAL. You see there is this thing called a statute, its the the thing that tells the FDA what they can and cannot do. What you are seeing is the FDA telling the company that they have seen the data and they get it. That said the company needs to present the data in a way that meets the requirements of the statute. There is not 30 years of history on this process...it is brand new and both sides are feeling their way through it. They are not taking the wink to file for AA lightly and that is a good thing. BTW no complaints in the minutes about small number or single center issues. This may sel off and your technicals may have a place in finding support but Adam F, Baird and Piper have this one right.
I don't know you but you have posted with vitriol against me before. I forgave you for that as you are entitled to not like me if that is your wish. I do resent though, that you feel you have some special authority to tell me what I can and cannot post on this board. I believe I went to bed in the United States where there are 1st Amendment Rights (that both my son and I personally fought to protect;) and I know I woke up here as well; so we do NOT have Kings and we do NOT allow others to tell us to shut up just because they disagree with us. In a prior life, I worked with the FDA, so I'm not in need of tutoring from you, but thanks anyway.
Whether you like it or NOT...the hard, cold fact remains that IF SEREPTA MANAGEMENT CAN GIVE THE FDA THE SUMMARIES IT DESIRES FOR SURROGACY AND TEST RESULTS NOW, IT CERTAINLY COULD HAVE GIVEN THE FDA THAT DATA BACK IN MARCH.
Though your CENSORING behavior is UNACCEPTABLE to me, YOU personally are not at all, and I offer my LOVE and HELP to you as the Lord has asked me to do with ALL on this message board.
God bless you...Bud Rolfs
We were waiting for the results of the meeting with the FDA. Yesterday we found out what is needed. I don't see how this is a negative. If like some were implying the FDA said the trial was too small and a larger one was needed that would have been a negative. They are only asking for details for a path to possible approval..... Sounds good to me
I will continue to look forward to the longer term; BUT today we have about 100 posts celebrating how GREAT THIS NEWS REALLY IS and how STUPID the rest of the world is for not realizing it.. I do not think we have to go quite that far in our loyalty to this stock. I guess I've just been on way too many message boards the "MORNING AFTER" and when their pet stock screws up, a lot of people feel a need to come out and salute the Company Flag and say how wonderful it really is to get sucker punched....
Just venting a bit....Bud