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Re: Biobillionair post# 217878

Sunday, 10/06/2019 12:01:01 PM

Sunday, October 06, 2019 12:01:01 PM

Post# of 425618


27. Defendants responded on August 27, 2019 that they have understood all along that the parties’ negotiations concerned all FDA correspondence concerning the sNDA. After all, the whole point of Amarin submitting an sNDA to the FDA is to gain FDA approval of the sNDA.

28. On August 28, 2019, Amarin accused Defendants of seeking to alter the parties’ agreement and reiterated its “compromise” offer to produce FDA correspondence “concerning the timing for FDA approval.” Infra, Exhibit 7 at 1.
29. On August 29, 2019, Amarin produced another set of documents that included
FDA correspondence relating to the sNDA dated up to May 2019. However, Amarin is stillrefusing to produce all FDA correspondence regarding the sNDA, as evidenced by the Amarin press release referencing correspondence with FDA in August 2019 which Amarin has failed to produce.



Bio,

It seems they want correspondence regarding ADCOM letter.

But JT told you there was none? All the information that they knew about was written in the letter?

Kind of confused here.





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