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Re: sts66 post# 308767

Sunday, 11/08/2020 11:22:22 AM

Sunday, November 08, 2020 11:22:22 AM

Post# of 447687
Thanks for the analysis sts-you may be right --we will have to wait for someone to procure some HIKMA gen V and subject a batch to independent analysis. IF so, then this is very bad indeed for patients. The least the FDA has to do to ensure their statement (in the ANDA approval for HIKMA generic IPE) regarding "therapeutic equivalence" is true is to match the 1g dose equivalent of IPE with that of Amarin vascepa. I accept the molecular weight differences but the density assumptions may not be identical--at any rate the two tablets for 1g IPE are 25mm long other dimnesions being unavailable. It is all the more reaso why there should be a ehad to head 2x2 crossover lipid and serum EPA level study done by Amarin and if variant to expected or subtherapeutic EPA levels teh data should be submitted to the FDA as soon as possible.
HK
If we all wrote a petition to JT it might take root in his mind...
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