Geeesss larry...moe did not post it....sent it to curly thru other magical means.......curly then posted it on iHumble.....glad it was of help....now sleep tight......gotta go....Pfizer Q4 is starting........they will obviously being talking about the Advil Response......yeah right.....
Due to some weather related issues and that my work computer does not let me go to just any site, I did not go to that link.
I have to use my home computer to actually get stuff done like read a link.
(it's a security issue)
Part 3: Under these circumstances, it would not be in the best interest of the public
health to opine that we will categorically deny approval of any generic EpiPen autoinjector
application solely on the basis that it is not exactly "the same as, without
limitation," the RLD auto-injector.
For the reasons stated above, we decline to determine that generic versions of the EpiPen
auto-injector must categorically have the same design, operation, and function of the
currently marketed EpiPen auto-injector, including without limitation the same human
factors engineering attributes such as color, shape, ergonomics, container, and needle
protection mechanism, to qualify as the "same" as the RLD.
Cont. Second, your request would have the practical effect of categorically inhibiting any
differentiation, however minor, between a generic and innovator epinephrine autoinjector
product. As such, it would run counter to the Hatch-Waxman Amendments'
intent to balance the need to encourage innovation with the desire to speed the
availability of lower-cost alternatives to approved drugs. As described in the response to
the King Petition, for a combination product approved under section 505 of the Act, we
will consider whether particular auto-injector design changes would require data beyond
that which can be reviewed under section 5050).
Third, while the Petition suggests that any change in a generic version of EpiPen autoinjector
raises the possibility for patient misuse and therefore significant safety or
efficacy concerns, we note that Dey currently markets both the new and older versions of
the EpiPen that actually have design differences from each other of the type that you
assert are critical. FDA did not limit in any way Dey's ability to market both designs
simultaneously while existing supplies are depleted l2 We note that EpiPen is marketed
with a trainer product, and therefore, any generic EpiPen injector would be also required
to have a trainer product. 13
Some additional verbiage from Tab 1 of the petition:
First, there is no requirement in the Act, implementing regulations, guidance, or Agency
precedent that would mandate as narrow an interpretation of sameness as you would have
the Agency adopt. We reiterate our position that a generic and innovator product need
not be exactly the same in all respects, although they do need to be appropriately similar
in design to ensure the safe and effective use of the product. To further clarify our
position as described in the King Petition response, we note that in assessing whether
differences in a generic and innovator EpiPen auto-injector do not exceed the bounds of
sameness such that safe and effective product use is called into question, we would not
only examine the individual attributes ofone or several auto-injector differences, but also
the combined effects of those differences. When further evaluation is needed, the
Agency may (1) require additional bench testing or human factor studies or (2)
recommend an alternative regulatory pathway, such as that established under section
505(b)(2) ofthe Act. In any event, our analysis ofa generic EpiPen auto-injector product
would be conducted on a case-by-case basis and not based 'on a rigid adoption of specific
product attributes ofa generic product that would be required to be the same as those in
the innovator auto-injector.
Music...sweet, sweet music. And I still can't find anything that would allude to Sandoz having a competitive Epi product in the future.
Sentiment: Strong Buy
Loko, it was indeed a good link. If you post after midday don't delete before 7PM or I'll probably miss it :o)
Sentiment: Strong Buy
see cache...no reddies.....and even some comments....along with additional related posts springing off from it.......life must be blessed for you..........that would not have happened if loko posted the info earlier.....a redthumb magnet along with whogo........... they just don't know what they are missing........guess the old idiom fits......."What you do not know won't hurt."....
Anyhoot...a lot of good, bad, and stupid info listed in the filing, posting the link directly to the filing on iHumble helps get readers to the right spot......and.....ryman appreciates maintaining the site for posting loko finds, and happily enjoys the temporary increase in traffic to the site....... the lonely Maytag Repairman site.......reading all of the filing attachments should answer most of the questions people had...and more .....
Oh well back to a more important real world crisis, that purple people eater AI.....oops lavender Ai.......and the "Push Button" patent that goes with it.......Like that name...something loko knows all about......
Lady, did you go to the link and read the whole letter? It is well worth your time, and yes Loko is the best here in finding the really good stuff.
florestan, Hobbs actually said more than that.
"The FDA has outlined the steps necessary to support approval of the ANDA, and we plan to work closely with the Agency on a response.”
I think whogo has, in his post, listed the revenue. cut out G&A and cost of sales etc. and you'd probably have about a 1.5 mil profit (after the profit split.)
How the heck did loko find this? flat out amazing!
Thanks to loko for finding this and thank you Nam for posting this.
This kind of read makes my morning.
can't please everyone;
If there was no press release, people like you would complain.
If there is a press release, People like you complain.
Take your pick.
By the way Epritske I hope that SYN and NLST plus off course ATRS all get back to the level you bought them at and continue upwards from there. I get no joy from seeing people loose money in the stock market or anywhere else for that matter.
epritske • 3 hours ago
This Today on SYN
Yes expected phase 1b results and the start of phase 2 Jin few weeks...this was my 2015 top performer on Andres list...if Nam is reading don't worry Atrs is the best stock ever that always goes up and never frustrated you....the management is superb despite changing often. Atrs to the moon
Now Epritske has been in SYN for a long time.
epritske • Feb 21, 2014 4:06 PM
0 users liked this posts users disliked this posts 2
Anyone still in this? I bought more syn today and bougtht more nlst...Sold everything else except atrs which is long hold.
At Feb 21 SYN opened at 2,73 yesterday it opened at 1,50 and closed at 1,72
At Feb 21 NLST opened at 2,39 and closed yesterday at 1,56
So Nam asks again Epritske the great investor how do you pick them?
So Epritske I'm not as worried about ATRS as you should be about your portfolio.
This was on the syn board to :)
Barring any fantastic news---Syn will hit 1.96-2.04 and that's when I play again
Congrats to those who held on the last couple of months. 1.96-2.04 is where this will top out.
I went over and had a look at SYN(at least you are posting there) They where at 3,45 on March 19 2014 and Started yesterday at 1,50. Nice jump to 1,72 must be a spectacular company.
ATRS is down about 50% since the short attack started. Syn is now down 50% and thats after a one day jump of almost 20%. So whats the magic?
Only problem is, he didn't say that at all. He said he was pleased by the feedback the FDA provided. There IS a difference.