FDA Grant Fast Track Designation to ELND005 for the Treatment of Neuropsychiatric Symptoms in Alzheimer's Disease
Last update: 7/17/2013 4:31:00 PM
TORONTO, July 17, 2013 -- Transition Therapeutics Inc. ("Transition" or the "Company") (TTHI) announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation to the development program for ELND005 which was submitted for the treatment of Neuropsychiatric Symptoms (NPS) in Alzheimer's disease (AD). The FDA concluded that the development program for ELND005 for the treatment of NPS in AD meets their criteria for Fast Track Designation.
Transition's licensing partner, Elan Corporation, plc ("Elan"), is responsible for all development and commercialization activities and costs of ELND005.
About Study AG201
The objectives of Study AG201 are to evaluate the efficacy, safety and tolerability of ELND005 over 12 weeks of treatment in patients with moderate to severe AD, who are experiencing at least moderate levels of agitation/aggression. The study is expected to enroll approximately 400 patients at multiple sites in the US, Canada and other selected regions. In the Phase 2 AD Study (AD201), ELND005 appeared to decrease the emergence and severity of specific NPS, an effect which seemed to correlate with drug exposure for some symptoms. ELND005 also led to a sustained reduction of brain Myo-inositol levels that are thought to play a role in phospho-inositol signaling pathways and synaptic activity.
The stock closed today at $3.08. After the news, TTHI is now trading 32% higher in after hours session at $4.07. Check it out, market realists, and let the other two bash! :-)
Quarterly financial results today, after the closing bell. From about $4.00 per share then after this news item first broke, the stock was last quoted at...
TTHI: $6.70 -$0.07 -1.03%
Up 67.5% since date of rec!
if you looked at Germany and what happened in ww1
please go read history that is how it goes.
ww2 was caused by ww1 hilter came into power because of the desperation of what the allied powers put upon it and extracted wealth using interest by the banksters.
as a result people wanted hitler to purge them of those. but by doing so they let a monster control them as well and started another war.
many millions died as a result
when banksters like you do this you are the ones responsible and deserve to die more than Hitler.
too bad many do not know which ones to arrest and shoot down lucky you ain't it?
more recently it has been going on in Greece as well.
look at Greek news and you will know.
how unfortunate that idiots keep harping on but ignoring the reality and state of the world.
unfortunately people think this place is the center of the universe or something.
in a sense it is as the wealth is being absorbed by others giving up theirs and their lives to foster this place.
more qe = more inflation in other areas of the world causing more rebellions and death and misery.
and many finance people think it's fine.
thieves will be thieves what else is new.
dictatorship - capitalism- socialism- fascism - communism
then to dictatorship and then capitalism again.
we are at the fascism phase
we are long since past capitalism.
the decay and rot is accumulating again and may eventually lead to communism.
then another monarchy/dictatorship and a rebellion again
oh btw to those that respect warren buffet like jon carnes.
did you know warren buffet disowned his grand daughter because she thought her family had too much money and said it on camera/film?
that film was done by johnson and johnson grandson/son
so there are some in their families that feel guilt of having so much extracted by the ponzi sham.
money compounds itself when at the top because of 0%.
really though most rich people need to go bankrupt to disperse them back into the economy
creative destruction boom + bust, creation from after destruction.
therefore new productive wealth will be created if the system goes down.
the current fake wealth needs to be taken down as it has been utterly corrupted.
end the monopoly game and start a new game.
just giving everyone infinite amount of debt never ending the game wont change anything.
press the reset button.
then there is google.
what is preventing them from achieving what they want is data plans being too expensive.
do you really think people want ads on their phones especially when there is a data cap and ultra expensive plans?
that filters out 50-80% of their market base same with facebook.
why is it profitable for them on mobile hmm? it is merely an instant messaging service.
kids use phone with all those things
because they do not pay themselves.
their parents do.
as a result I hope most of the spoiled brats from rich families bankrupt them.
also laptops + apple iphones profits may die even faster the faster 3d printing and such diy technologies emerge and prosper.
can you control people from creating things themselves? PROBABLY NOT.
the reason why people like iphones are because mostly the CASE DESIGN and then OS on a small note.
the feel of Iphones seemed higher class that's all.
the parts inside are actually just as cheap as other phones
made by foxconn a Chinese company anyway
so is asian vest protesting foxconn too now?rofl
but anyway back to topic.
laptops case design = better on apple end again.
now everyone copies it.
the reason why people didn't do so before was because of the engineering standpoint it was not so good.
using aluminum to create the case was a bad idea for wireless frequencies.
there will be more heat and signal disruptions.
so the engineers would need to think about those things so it would not disrupt the frequencies.
even APPLE had problems at first and failed initially with the iphone antenna debacle when they went with aluminium casing.
same with laptops.
and yes what is this about patents on round corners? are you financing idiots stupid?
anyway when will you admit oopsie that the economy is a ponzi scheme in general?
you and asian keep spamming about china but in reality the world itself is a ponzi scheme helped by your bosses to manipulate it to help transfer the resources to your bosses?
hmm? just admit this already.
fact is I invested in DDD before you even looked at it because I liked 3d technology as a way to help transfer back the power to US people.
but in reality DDD margins may go down as hackers/innovators/engineers/programmers disrupt their market share.
because there are in fact better bang per buck method to make 3d printers.
lazy people will buy them
smart people will build them.
they will be as easy to make as PCs eventually and eventually it will become like the PC market.
the reason why the PC desktop market for consumers died down in profits is because it is saturated and easy substitute.
the substitution = DIY PCs they were FORCED to lower prices by hackers.
because too many people knew how to make things themselves.
all manufactured products will come back NOT as JOBS but as people doing it themselves.
unless companies invest in productive capacity and automation to lower their prices to near NIL much cheaper to buy it than to make it basically.
or lower than the cost of MATERIAL.
PS PATENTS are in fact preventing innovation and setting us back centuries in possibilities.
it was because patents expired that 3d printing was made possible because the key tech in 3d printing was being controlled and royalties were too high.
Besides, I'm not apologetic nor sorry for your apparent inability to read this Topic's title nor adhere to refrain from replying without being an investor of the stock market with logic and sound mind for reasoning. Otherwise, realistic. Geez, who'd have thought that You'd be on who'd fail to follow the request with any semblance of civility. Pity you.
P.S. Pardon also that the stock you love and have been pumping higher to $4.68 and $8 is slipping support at $3.13-ish as my OT rec seeks to break $440s-$4.50 reziz w/ floor area at ~$4.20 now. No sorrow to you, ich.
What a wuss! Why not simply place my ID on ignore? You've said "not to listen to anything I say," so why not do that? Not a big man, i.e. can't act as a gown up and adult??? Gee, I could have done likewise and reported you for touting "crude oil to $150" and hyping WARS breaking out, both off topic garbage! Guess what though? It doesn't matter to me what anyone posts about, as long as it has something to do with markets. You, however? Well, you're getting your head handed to you on EVERYTHING you tout and you just cannot handle the truth. Too danm bad! GFY and cry to someone who might sympathize with this pathetic whining.