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Sluicebox

03/31/20 7:17 AM

#258603 RE: raistthemage #258533

Didn't Dr Reddy already file the ANDA back in 2014 , which is why we have been at trial ? So they already filed it, so how long time will it take FDA to approve it. Does the ANDA have to resubmitted now that it has been "cleared" and go though aa hole new process ?

biotechtrader2020

03/31/20 7:56 AM

#258643 RE: raistthemage #258533


>1. Thero and Kennedy are now extremely likely to be fired
They might be fired, but our stake in amarin is already reduced to ashes.
I hope they sell the EU rights first before we end up doing multiple reverse splits and visit penny stock land.

>2.has a good chance of being overturned by the appeals court or perhaps even the patent office...
We had a good chance going into this case - the appeals process is 2 years long and the odds are worse than what we had going into this case.
In the following case, AZN posted bond of 72 million ($1.2 billion of pulmicort sales) and lost 2 years later.
Given that we doubled the sales force and expenditure recently - we first need to see the impact of bond amount on the balance sheet and daily operations.
https://www.astrazeneca.com/media-centre/press-releases/2013/us-appeals-court-temporary-injunction-pulmicort-respules-25052013.html

>3 FDA cannot accept any application until December 2022.
Are we sure about this? what is your source/rationale for coming to this conclusion?

>4. This is not the best drug for generics to compete with.
This is the absolute best drug - the margins are high. Do you think the companies that managed to pull a victory in this hard-to-win case did not do their diligence? JT is not running the generics - they know what they are doing.

>5.AMRN is in a position to create supply difficulties for generics.
We will find out soon enough. As I see it AMRN is in a position of creating extreme difficulty for AMRN. Generics are doing just fine.

>This ruling has no bearing on foreign countries.
I hope so. But this company has an exceptional record of crushing hopes.

>The short position is likely to cover here.
They either cover now or they cover at a lower price and make more money.