I think that it is receiving notice of the Article IV certification that starts BOTH clocks, 45 days to sue for infringement AND 30 month stay of FDA approval. The 45 day clock starts and the 30 month stay is conditioned on filing of suit within the 45 days.
In news today, a Bank of America Merrill Lynch analyst gave the period ending date of January 16th. This indicates that the clock ticks with Teva receiving notice from Momenta versus the legal filing date of Teva to protect patent.
It is my understanding that the clock starts the day Teva files its lawsuit. On July 11 Teva announced that they "anticipated receiving notice" upon which they have 45 days after receipt to file lawsuit. Lawsuit was filed August 28, 2008.
Please correct me by citing reference if I am wrong.
Addendum on expiration of 30-month clock for generic Copaxone: The Hatch-Waxman 30-month clock (during which time the FDA cannot issue a final approval of NVS/MNTA’s Copaxone ANDA) started on 7/11/08 when NVS/MNTA notified Teva of their Paragraph-IV certification for Copaxone (http://www.tevapharm.com/pr/2008/pr_771.asp ). The clock thus expires on January 11, 2011.
After 1/11/11, the FDA can issue a final approval of the Copaxone ANDA whenever the FDA sees fit, without any regard for the status of the Copaxone patent litigation.
Here's a good example why. Check out the chart on another company I own SNMX. The price dip in mid feb is because they did a secondary at about $2.60. Now it's trading at $7.50.
Oh no, the stock I KNOW very well. How well? Let me put to you these undisputed FACTS with a common denominator: % it went down since highs in Summer AND % of float currently (as of November 30th) short: 30%.
I don't suppose you will argue that.
As for your 85% gains (paper), they COULD continue dwindle, you know?
We are less than 2 months from the expiration of the Hatch Waxman exclusion period for copaxone, This means that FDA can approve MNTA/Sandoz application any time after February. The FDA does not and should not wait for the litigation to run its course. That process is separate from the orange book patent considered by HW. Assuming an FDA approval, it would then be up to MNTA and Sandoz whether they launch at risk.
This combined with the m-enox earnings make for a nice upside even above $14.35.
I'm not here to give you advice. I would like to advise anyone reading this message board that you don't know what the hell you're talking about. By the way, I'm quite happy for the moment with my 85% or so gain to date on MNTA shares. the fact is you don't have a clue about this company or the stock.