Srpt CEO is on vacation with star for 2 weeks
adjust your schedule accordingly
RNA targeting Q4 2014 for possible commencement of redosing
so clear signal given on what the backdrop of redosing will be
I continue to believe RNA will make an attempt to file some kind of NDA in 2014
RNA preliminary forward plan is confusing, as it appears to target younger boys, where natural history makes it difficult to show SS improvement
as for the RNA 2014 cash burn guide:
"For 2014, the financial results of the company will be influenced by the outcome of our current interactions with regulators and that now represents potential path forward for drisapersen. Once we have more clarity on this, we will be in a position to provide updated financial guidance on 2014."
IMO, this means an RNA cash raise is coming
this enables me to declare my new price target of $96, which if I am not mistaken, is the cost basis of every long on this board (data source: our friend nekkid)
zixi to 96!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
they should start off with something like this
"that xxxxxxxx fda is xxxxxxxxxxx totally xxxxxxxxxx off xxxxxxxxxx base and they xxxxxxxxxx have no xxxxxxxxx idea who the xxxxxxxx they are xxxxxxxx messing with"
institutional holders selling to lemmings from literally the open
there was never anything real unless you know the exact ages of each boy in each cohort
same applies to the data relating to after dosing stopped
ages of boys would determine if it was real or memorex
I would wish that it is real, but there is no real way to tell on released info
let me first disclose that I am not a doc or scientist, but rather, an official pond #$%$ sucking bottom dweller, and an unofficial stock monkey (stock monkeys are either one step above or one step behind stock jockeys, depending upon your bent)
also, I can read, and english is a strong second language for me (I have no first language)
after reading everything I could find on the RNA P2, my conclusions are as follows:
1. Dr. Craig McDonald, you little devil, you ...
2. the idea that a dmd boy might show any kind of lingering benefit 24 weeks after dosing stops is most worthy of further review, no matter what company is involved!
3. dmd boys between ages of 5 and 7 can continue to show good 6 mwt results, naturally, without any drug
4. it appears impossible, on current RNA disclosures, to even generally guesstimate the ages of the boys in each of the applicable cohorts used in the RNA release, thus is appears impossible to accurate weigh the value of the data
5. "clinically meaningful" and "statistically significant" appear to be spelled differently, at least to me
6. the disparate ages of the boys in all the RNA trials has plagued the RNA results from day 1, and those with memories may recall the RNA CEO has publicly said this previously
7. the timing of the new RNA release is most likely not happenstance
8. Dr. Craig McDonald, you little devil, you (worth mentioning twice)
let remember what he REALLY said
he said his price target was raised from 4 to 7 (he knew he could not find any defendable way to say more)
but then he said the following ...
IF THE COMPANY FILES AN NDA, THE STOCK COULD GO TO 29!
that is the functional equivalent of me saying the following:
IF I BREATH AIR, THEN I SHOULD BEAT LEBRON ONE ON ONE!
he made a stock price prediction off an event that he knew actually meant nothing of substance
I cant wait to see what he has to say tomorrow
you have to distinguish NDAs filed off P3 with those filed off P2
off a P3, RNA will not be looking for a wink from FDA before it files
if it can mine the P3 data, it will file, and will act like data mining inside a P3 and filing off that is the same as filing off all the P3 data: when in reality, that is like comparing apples ... and ... muskrat feces
for the luv of God, read the rna pr for what it really is
which is more of the same
the data cannot produce SS results because the age groups are too skewed
they need to mine the data
and they will, and then they will file an NDA
which is why Furlong recently said she will support any company that files an NDA - she knows the RNA NDA is coming
as for McDonald's role as chief investigator, no further explanation needed on his FDA involvement
WHAT I DO FIND MOST INTERESTING IS THE IDEA THAT A BENEFIT MAY LINGER EVEN AFTER DOSING STOPS
NOW THAT IS WORTH FOCUSING ON, AND SHOULD BE TRANSFERABLE TO SRPT
Moultan was discussing the build up in the cells issue earlier today
NOW THAT IS EXCITING, FOR ALL THE DRUGS
read the call transcript and see EXACTLY what he said, which is not what you just said
how many shares do you think will trade on the fated day that the company provides its FDA update?
my guess is at least 12,000,000 shares (at least!)
that is the easy part
the direction of the trading is the, um, hard part ....
I continue to believe the FDA gives the company a very reasonable P3 requirement