by the FDA (Dec22), the stock was at a split adjusted 20. After the groth hormone was aproved, validating ALKS's technology, the stock took off to about 30 . For about a year after 2000, it bounced between 20 and 30 for more than a year until a few months earlier when the market brough it down to 20 then the
Given the fact that the technology has again been confirmed by the European approvals, why does one think it would take a US FDA approval to get this stock back to 18-20? A rough estimate would say it should go to 50 and beyond in short oders.
If we need to do the rodent studies again, it will take no more than 1 1/2 years to do so. The natureal life span of mice is about that long anyway. Conceivably, JNJ can neogitate with the Fuc'ing Dept of Attitude for conditional approval before then.
Consta is a solid product, as numerous investigative sites and European approvals have shown. The silence after APA presentations was a signal (my interpretation)that FDA was having a problem. Problems with inhaled products stem from continued concerns with the technology, re : INHL and others.
"You probably thought Consta would be approved by the FDA too...didnt you. Shame you did not take post 1580 seriously..oh wait...were you even here back then?"
1. Hmmm. Apparently you forgot about your post 1579. Just to refresh your memory, here's the link:
If you're trying to imply that you were somehow prescient regarding the ultimate FDA nonapprovable letter -- forget it. Here's a quote from your post:
"Injectable Risperdal should be solid, but inhaled products may still be problematic, unless you live in New York City. What % of pipeline is inhaled product?"
2. I did not [RE-]invest (see below) in Alkermes until Aug 1 and so I paid little attention to this message board in late May -- an exception was "warsurplus1"s silly posts about ALKS hitting a "6-year low" in early May. Are you related? Identical? LOL
2. I was a VERY early investor in ALKS and cashed out when it hit "nosebleed" levels -- making me a tidy little sum of MOOLAH. I even 8X'd a $4K wager in ALKS Calls during that time though my REAL investment was approx 4.5K shares of common -- equivalent to 9K shares now, post-split. However, I have continued to keep an eye on the company news and stock price action. My CURRENT investment in ALKS is trivial compared to previous, since I believe the bear market has just begun and, given ALKS's debt load . . . who knows.
So, new_to_the_game_00, you've been "following Alkermes" for a WHOLE YEAR!!! WOW!!! I'M IMPRESSED. LOL.
As I said, you have ZERO scientific basis for your "anticipation" of stimulation of antibody production by the PEPTIDE, exendin-4.
What a doofus/poseur (and waste of time) you are, "new_to_the_game_00". But, good for a laugh. LOL.
The point is the FACT that Medisorb� (unlike ProLease�) is used for delivery of SMALL molecules and peptides, e.g., exendin-4.
As I said, that should be a CLUE, since such a small foreign molecule, unless attached to a macromolecule (and it is NOT), typically does NOT induce antibody formation. That is why your analogizing exendin-4 with Enbrel and Remicade, both macromolecules, is INAPPROPRIATE.
"new_to_the_game_00", you are truly CLUELESS, even though I provided you with a clue. Not only do you fail to understand exendin-4, you fail to understand Alkermes' technologies.
As I said, if you have ANY evidence for your "anticipation" of immunological problems with exendin-4, POST them. You don't because you have NOTHING.
You know a few facts, have no conceptual framework (SCIENCE) into which to place them, and, consequently, your opinions are unconstrained by understanding. That's bad enough but you also apparently feel compelled to propagate your invalid imaginings. Fight that compulsion. PLEASE. ;-)
type of antibody response they are seeing IgG, IgM? Also, is this a neutralizing antibody. There is no doubt that antibodies will be formed in a percent of patients. Four implications arise; do the antibodies inactive the protein?, do the antibodies change the elimination (pharmacokinetics) of the protein?, do the antibodies fix compliment? do the complexes deposit in the kidney or other organs? Insight on any point would be apprecaited.
BTW: antibodies to Enbrel and Remicade were not concidered to be problems before either product was released.