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Re: Protector post# 101389

Friday, 11/09/2012 9:52:46 AM

Friday, November 09, 2012 9:52:46 AM

Post# of 346441
Agreed. I do not expect them to publicly state the impact of the error, rather, I would expect them to communicate where the 2nd line indication goes from here. It is possible to move forward into phIII and still have a claim against the third party (i.e FDA signs off but claim is still for lost time, forfeited fees for loan, etc). Likewise, it is still possible that we will not move forward and have no third party claim (i.e we were complicit in error). This is why there is a need for an internal investigation. If we want to claim third party error and win suit, we also have to make sure we had no role internally that could have helped cause the error or made it worse (you do not go to a gun fight unless you know how many bullets you have or if one of your guns doesn't work).

If you are going to say it is there fault you better know you didn't have any part of the error or do anything that could have led the third party to do what they did because if you did it will come out later.

So, I would say we will get word on what our next step is in the drug approval process but I do not expect to hear ther impact of the error until the lawsuit with CSM is played out. The next step will tell us a lot about what the impact was.
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