may I quote Prez Reagan?
THERE YOU GO AGAIN!
I never in the past did, do not now, and never will, tweet under the name "stockerjockey"
in fact, I have never even seen a tweet by a tweeter who goes by that name!
I can swear on a stack of bibles piled from here to Kingdom Come
and if you turn your brain on for a minute, you will see why I can say this
but lets turn positive
everybody has their strong points, including you
you are professional when it comes to name calling!
I will see you on twitter!
oh wait, no I won't
I just remembered that when you were called names over there, you took your sandbox private!
you just accused nekkid of beating a dead horse
I so miss the civility we used to have around here
now look at us
we just beat up on each other, and on tree bark
we must restore the mullet code of honor
I am sorry to hear about your memory loss
I recommend aricept!
because, apparently, you have forgotten all of your prior accusational postings towards me
my memory is fading, but still functional
and I still remember how to swear!
so go f yourself
I assume you guys have seen it
I suspect that once the rest of what these folks are doing is out, everybody will understand why Srpt has to be neutral to them
you get a hint of it in the utube video
they flatly acuse fda of bad behavior
she did not have a single, solitary Srpt - related scientist even invited, let alone speak
which is why she did not ever publicly list the names of the experts attending the event
ever other PPMD pr I looked at always named the attendee's
but not this one
STILL not this one, even as of now
Wilton was a force in
I really do hope you are correct
but I have heard many, many things about this December 12 meeting, and how it was orchestrated, which do not support your thesis
and I am not the only person who has heard them
in a very best case scenario, Furlong would be a harmless person who has been totally manipulated by a core group of people, ALL OF WHOM HAVE DIRECT FINANCIAL INTERESTS IN THE MATERIAL DELAY OF SRPT'S DMD PROGRAM
things I have heard suggest the actual facts have her on the other side of the ledger (the bad actor side)
read the post to which I am responding to
I believe Wilton will now be at this event
the deck is still stacked, but now a bit less stacked
I do not believe this is the case with an "AA" NDA
in such case I believe the FDA can choose not to file it as premature
but in between needless splitting of hairs, I get your point
sometimes things come from actual human personal communication, as opposed to twitter, facebook, myspace, snap chat, email, message boards, instagram, carrier pigeon, morris code, etc.
I believe wilton is now more involved than before
hi this is nekkid
you appear to have forgotten that you bought in at 96
I determine the price you bought in at
which means I set your ROI
and tmwd was a good buy at 16
Formal fda meeting minutes coming at some point in december 2013
no comment on meeting other than "productive, constructive" meeting in late november and now another meeting scheduled for december 2013
and now we know the Abigal letter to Woodcock was sent right in front of the November 21 FDA meeting
the letter was perfectly accusatory
that meeting must have been "fun"
if you take the Abigal letter, turn it side ways, squint your eyes, and then blink twice, you will see that the letter is a hologram that actually says the following:
I am calling you by your first name because calling you "Dr." is unbearable at this point. You and I were in the same room, twice, and I do not have memory loss, nor do you. I remember exactly what you told us, and so do the activists who met with you several times after I met with you twice. You need to decide if you are (1) a total liar, (2) completely incompetent, irrelevant, and/or (3) both. Please tell me you are ashamed of yourself, so that I can regain some faith in humanity. I strongly advise you fix the complete disgrace you have, on purpose or by incompetence, foisted on the dmd community. Because if you do not, we will never stop until you are gone from the FDA."
my own personal take is that woodcock is honest but completely incompetent in her behavior on this issue, and that she got steamrolled by others at the FDA, which is why she allegedly sat in the November 8 meeting and did not utter a single sound
this is the highest and best summary of the FDA fiasco that I have ever read
what a complete and total disgrace
you must read this if you desire to have your blood pressure elevated to 300 over 200
I have no clue what he will talk about, besides what is already publicly known
I continue to wish he was not speaking at all this week
unless, of course, he has FDA minutes
but if he did, I think it would have been on the tape first
will he attempt to address the situation in some kind of mealy mouth kind of way?
I suspect he has to try
but I also suspect the market will be much more scrutinizing now, without the minutes having been delivered
looking back on the disclosure in July that the FDA had requested Srpt to see if the trial parents would agree to a 4th biopsy, it now appears the read on that request was generally wrong
as I recall, the general read on that FDA request at that time, was that it was a bullish signal, in that if the FDA was going to determine the trial size was too small or that the clinical benefit was not sufficient, then why make a radical request for a 4th biopsy?
this made sense to me, then
now, given the new disclosures on November 7 thru 12, my take is now very different
I think that FDA request, which probably came from supporters inside FDA, was a signal that things had gone very wrong with the FDA Nuerology Division folks on the Srpt dystrophin measurements
one name is all you need: DR. ERIC HOFFMAN, who coincidentally, was at that time slamming the Srpt dystrophin measurement process with the FDA, and was also peddling his own measurement process, for hire
and this is my guess: if the parents had agreed to do the 4th biopsy (which they obviously did not agree to), such biopsies would have been conducted with Hoffman doing the dystrophin measurements using his own developed technique
again, that FDA 4th biopsy request was bigger bearish signal than was probably realized at that time
and this new Hoffman intermeddling fits perfectly with his prior May 2012 behavior regarding the Srpt trial
Hoffman allegedly called the Srpt dystrophin measurement process #$%$"
IMO, his self serving, conflicted behavior of the last 18 months makes #$%$" look like scrumtuous chocolate pudding
in other words, I think he is #$%$