sounds like there was an uptick in the number of parents who decided to agree to the biop
I continue to believe the 4th biop result is critical to the fda process, just like the d recount
ambulatory benefit is now open to all kinds of debate (natural history moving targets, now even steroid beneifts short term, bla bla bla)
but the restoration of a reliably measured amount of dystrophin, and what that can mean, especially when drug given at younger ages, is not open to nearly as much debate
show me good recount and 4th biop results and IMO, this situation graduates from lottery ticket status to something that absolutely must be approved by FDA ASAP
it might take 5 to 8 years to really know for sure what it does, but absent something better, the fda has to approve if d count is up and they accept the counts
the ability to turn an insider stock buy into a negative is a rare gift
CG has that gift
drown yourself in a mountain of new options priced at level that personally immunizes you from the entire preceding 18 month stock price drop
then, do a miniscule purchase, not even in the open market, but from a company plan, at even a material discount to the current stock price
does this have anything to do with the company's future prospects?
but its grade A evidence that the ceo is detached from reality and is a complete doooooooooosh
I have just read 3 of the analyst reports
The views presented therein do not match the bullishness expressed on this board about friday
this single quote from Wedbush was a common theme:
"In our view, there is still a long way to go; we believe a takeaway from the workshop is that at
present, dystrophin production can be supportive of approval, at best; we do not believe it is validated as a surrogate."
THIS WAS MY EXACT FEAR ABOUT FRIDAY
namely, the crack in the foundation of the only realistic basis for which etep could receive FDA AA
hoffman never said dystrophin should not be used as a surrogate marker
in fact, he completely supports this thesis
his entire issue is the manner in which srpt conducted its biopsies and did its d measurements
he thinks the way srpt did it was a joke
he has his own proprietary method of doing it
he has done a ton of damage since fall 2012
hindsight being 20/20, srpt management SHOULD HAVE KNOWN to get him in their tent
I often wonder where we would be right now, if hoffman was in the srpt tent for the last 30 months ...
the future is uncertain, but the past is locked
look at the entirety of the past in terms of FDA's ND and srpt interactions
I do not know how any rational, objective thinking person could not recognize that the ND has to date never gotten comfortable in using dystrophin measurements to validate dystrophin as a surrogate marker for AA consideration
it is not enough to just yell "crime" bla bla bla
ND has been hung up on issues of substance
the fact that others may disagree with its hang ups does not make them any less substantive
what is the purpose of this meeting?
to enable the ND to get past its hang ups? ... or to validate them? ...
take stock of the prior FDA public meetings on dmd related issues during the last 30 months (there have been two)
did anything positive flow from them or did they actually become more fuel for FDA lunacy?
the answer is lunacy, as the past record shows
no way to say for sure, but I suspect that dystrophin is the only realistic AA path for srpt (given the totality of the last 30 months), and bmrn knows this
the past does not universally predict the future, but its a real good start for the analysis
and in this instance, the analysis is not bullish in terms of the FDA conducting an event like this, at this time, with these people, on this issue
money is possibly God's greatest "objectivity destroyer"
IMO, if you are able to somehow extract the word "money" from your brain, I assume you would readily agree that the irrefutable very best thing for the dmd community would be for a large pharma to take over for srpt,'s dmd efforts via either partnership or buyout
(ask yourself this: where do you think the srpt dmd effort would be right now if a large pharma had either purchased or partnered with srpt 30 months ago? ...)
I suspect the size of the ZixDirectory will take a flying leap when all the Ironport users are populated into it
Having Cisco be the face of the marketing effort is a major plus
IMO, this is the best and most real pr from Zix in years, and should definitely increase NFYO totals quite quickly once the offerings are up and running
and imagine if with this, the Google sales become real again
yikes Zix will almost be real!
yes the devil is always in the details, and in most instances, the zix details have sucked over the years
but this could finally be different
I believe it common knowledge in the industry that Cisco has has multiple dozens of larger scale secure email clients (the kind zix has has generally be unable to get) using its Ironport offering
Most of those contracts are at least 5,000 user types, with many waaaaaaaaaaaay over that
the trick will be how many of those existing Ironport customers convert over to the new offering
my guess is at least most of them
as for the money, I assume there will be a per seat price, like there is now, and zix and cisco will share in that price (similar to what happened with Google before Google got f'd up)
we are all guessing here
but my guess is that this is the first thing I have seen in a looooooooooooooooooooong time which could actually FINALLY materially move the NFYO number
Zix 2014 NFYOs were $9ish million
a full ramp on Ironport could move that number by 50ish percent I suspect (i.e., guess)
bottom line: it looks quite real to this mullet
Roth must have been waiting for the new CEO, who starts Monday
11 boys in 4th biop
that is incredible beyond words and lends such credibility to the results (good or bad ...)
it appears the only boy out was the one with previous general anesthesia issues
no hep c update to follow on to yesterday's ebola update
radio silence could be here for a while pending pre nda meeting
this is not good news
but it is also news that any investor not in a coma should already be aware of
the company's market cap has been decimated in the last 6 months
its called increasing/material investor apprehension/doubt
I am actually surprised the IV total did not drop more!
IMO, the market is not always right, but is right more than it is wrong
the story here should have finally unfolded over the next 6-12 months
but in the meantime, increasing investor doubt (and resultant market cap reduction) has dominated the trade the last several months
in testing to date, drug has moderately less efficacy than at least 4 other compounds
drug is materially more expensive to make than other 4 compounds
drug delivery more complicated than other 4 compounds
largest ebola outbreak in modern history, srpt repeatedly advises all concerned it has a certain limited drug supply available, and the drug is not administered to a single ebola patient
in prior years, fed gov made multi-million investment in srpt ebola drug, but ceased program (choose whatever reason you want to espouse, end result the same)
this does not mean that srpt cannot in the future potentially garner a much higher market cap off certain of its other drug candidates
but IMO, you should definitely scratch ebola off the wish list
the weaker trade on mildish volume is not, per se, about anything new that was said on the earnings call
rather, it was the fact that today's call did not in any way mollify the concerns raised by the things the CEO said on the RBC call earlier this week
if you disagree in any way with anything I have said in this posting, then YOU ARE DEAD TO ME
One more thing short sellers and former chairman seller
It was a lottery ticket, you and the longs
Somebody was gunna win and somebody was gunna lose in this game of chance
You lost, real big
The royalties are big
if you are a srpt supporter/long investor, you should consider that the hoffman conflicts disclosure issue could be a material negative for srpt
the frosty relationship between the srpt ceo and fda ND staff is well known, and is considered to not have improved
that such staff attributed much of their bad press over the last 2 years to such ceo is also well known
and finally, that hoffman has had behind the scenes dealings with such staff on d measurement related issues, and that they considered his advice in their decisionmaking, is also well known
and now we have certain srpt supporters/followers who have taken actions against hoffman regarding his less than accurate conflicts disclosure certificate he filed with the fda recently
the result? once again, an embarrassing AND surely annoying situation has been foisted on the fda relating to dmd
do you think the fda staff further associates this situation beyond just dmd, and more specifically, with srpt?
do you think the fda assumes that somehow, the srpt ceo was involved in this situation?
if very recent directly comparable history be our guide, I suggest the answer to these questions is yes
do you think the timing of this situation is bad or horrible for srpt? (those are your only 2 choices ...)
do you hope this situation dissipates very quickly before the fda ND staff get any more annoyed than they probably already are?
because the enjoyment over watching hoffman skirm is misguided if your goal to have the forward srpt/fda relationship be better than the prior terrible relationship has been
and lastly, do you think the fda staff knew of hoffman's businesses even though they were not listed, thus leaving the staff focused not on learning anything new, but just focused on more annoyance relating to dmd AND srpt?
be very careful what you wish for
if the 4th biops were done and showed all boys producing dystrophin, and ANYBODY knew this, the stock would be trading waaaaaaaay above current trading trading range
end of discussion
I do not think the 4th biopsy results are anywhere near done
thus, I do not think the 4th biopsy results have anything to do with the recent options activity uptick from the buy side
what I do know is this:
srpt has the usual stable of high net worth individual investors, who are bonafide option/put crack heads/addicts, mostly from the option buy/put sell side
as best I can tell, they view all the money they seemingly regularly LOSE, year after year, on these bets as "the costs of doing business"
they make HUGE option/put "bets" regularly based upon their views as to the results/timing of impending binary events
I am sure they think the filing of an srpt NDA is a binary event
so why did their addiction grab ahold of them now?
Kaye's statements that srpt was "on schedule" for a "mid year" NDA filing, and their view that such statement should have a high likelihood of accuracy
cuz lets face it, there was nothing in it for Kaye to stick his neck out and jump on the NDA sword like he did, unless he was quite confident
if ever there was a time to say "further delay" and get away with it, it would have been now for Kaye, in his new role as the "clean up the mess" guy
so I attribute the recent call/put activity uptick to the call buy/put sell addicts, who fell off the wagon when they heard kaye yell "mid year"
and again, I attribute NONE of it to any impending 4th biopsy results