first, I think there is a parabolic public awareness event coming
second, the Q&A from the 5/21 presentation (which was not webcast) was key
in response to a question on future process, the CEO made it very clear that he was not sure what the process after the Srpt submission to FDA would be
he did not know if there would be a call or a phone call, or neither
the one thing he did say is that all the customary "rules" that apply to the end of P2 meeting process are not necessarily in play now
in other words, the FDA could get the stuff by 5/30 and respond with a short number of days
if you are long or short and are trying to "time" this, you need to understand that the CEO flatly said there are no rules now
it could be ANY day
if was short a large unhedged position in this stock I would need a defrib unit strapped to my waist
the public awareness regarding the srpt situation is about to take a PARABOLIC leap forward
this one is going to leave a mark
rice-cripsie, SO much more than a cereal
I would not characterize this as "pressure" on the FDA
its actually much, much more bullish than that ...
I say this because the fact is that the FDA has requested that the parents generate and submit evidence to the FDA of clinical benefits (other than 6mwt)
in short, this renewed flurry of activity among the trial parents is as a result of what the FDA has asked that they do
and it sure looks to me like the evidence they are generating, all across the board, is very, very credible/persuasive
forget about riceen
I am available
I have only 3 minor requirements
1. sex BEFORE the first date
2. don't bother me, ever
3. tolerate all my bad behavior
"I know my followers want more TA analysis from me, and frankly, God has asked me to dial that up a bit as well. Thus, my TA (which is irrefutable) says this stock should trade in a range from $1 to $250 over the next year. I would explain why this is so, but in reality, it is so far over all your lemming heads God has said I can just state my conclusions with no explanation."
now I (meaning me, simp) am a bit prejudice, because I am digging Patty's action, but I think this is the best TA I have ever seen
you forgot to also say that whatever richard does, it is all at my instruction (so I remember it being said on this board)
I am going to try to confirm this
dear richard, please write all your children out of your will, and write me in as your sole heir
also, please give me all your money and zixi stock tomorrow morning
and remember, the person who has said this over the years is never wrong, or so he says
so please do not break his "right" streak
they both say the same thing
get ready for an explosion in public awareness of this entire situation very soooooooooon!
as for riceen, that has been has "ceen" his better days
search "sheknows parenting Jenn Mcnary"
it should be the first article to come up
makes sure the search includes "sheknows", not "she knows"
"We’ve had three very positive meetings with the FDA in the past few months. We’ve felt very encouraged that the FDA is listening and is very interested in moving new and innovative treatments to the patients that need them, as fast as possible. I believe that accelerated approval will happen."
"In the summer of 2011, Max was eligible for a medical trial for Eteplirsen, a new drug that seems to stop the progression of the disease. Max has been on Eteplirsen for over 86 weeks now. Before the drug he was falling a lot, and beginning to depend on his manual wheelchair most of the day to get around. Now Max is very much like a normal 11-year-old. He can run, jump, climb and play, and he doesn't fall at all anymore. Kids with Duchenne always get worse, but Max and the other boys on the trial have gotten better or stabilized. This drug is life-changing and groundbreaking — the first drug of its kind to change the underlying mechanism of the disease, and give these kids a much better quality of life."
I believe the clinical benefits Max is showing, beyond the 6 min walk test, are even more compelling than commonly assumed. The reason I say this is because he is NOT believed to be one of the boys in the original 50 mg group with large improvement in the 6mwt. Rather, his 6mwt scores are thought to be flatish.
So to see him making such improvements in every day life type activities is especially compelling on the clinical efficacy of the drug. He is at the age where everything, in every way, degrades. Same thing applies to Billy, who is the oldest, yet his Mom says he has been stable in every day life for 2 years. I am certain the families are making the FDA acutely aware of all these "non 6 mwt" clinical benefits they believe their sons are experiencing.
insane is the word
if those institutional holdings still exist now, as tney did as of 3-31, and you factor in the latest reported short interest, then the available float in srpt is essentially down to zilch
now, it is possible that some or even all of those reported 3-31 long positions were reduced or even sold out in the heavy trade volume after the FDA "delay" pr in Aoril
no way to know for sure
my own personal opinion is that at least 2 of them own the same, or even more shares, now, than they did on 3-31
if the FDA agrees to file that AA app, this thing could explode beyond anybody's current thinking ...
given the reported institutional positions, if I were short this stock in any meaningful unhedged way, and my thesis revolved around the FDA requiring a P3, I am not sure I would be able to breathe right now