Amarin Corp Plc (AMRN)

[jessellivermore]

The NCE delay..or "As time goes by"

It's all very fine to argue chemistry..I have a degree in chem E. (they awarded it under the proviso I promised never to do any chemical engineering). At present I can't tell Ester from Ethyl, but I can look it up..

IMHO..The delay is not being caused by the peculiar structure of Vascepa...My guess is the hard core at the FDA do not feel Vascepa meets the historical definition of an NCE (PS..I am very long)..

The reason they (the FDA) have not dinged the drug is that they feel Vascepa should be awarded the NCE. At present the FDA is studying the NCE definition as laid out by Hatch-Waxman with the notion of changing it..The original criteria was that an NCE was defined on the basis of structure..for NCE exclusion the principal API should not to have been used in any previously approved drugs..The question is whether this is truly a fair or whether it unfairly excludes the type of creative thinking required to find novel uses for previously used chemicals...The PTO has amended its novelty requirements to allow use of "prior art" if the inventor can show he has discovered new and important usage not disclose previously...In many ways the NCE acts like a patent.

The other problem with the current NCE definition is that is fails to take into account the effects of progress on the fairness which was the original purpose of H-W...As new APIs are added to the FDA's OB, it becomes harder to find new chemicals..which results in fewer NCEs and less incentive for biotechs to try to develop new drugs..

Vascepa is no doubt, front and center in this argument..IMHO..reason and wisdom will prevail. If this is the case Vascepa will get the NCE...No guarantees...

PS..IMHO the NCE is not really very important for AMRN, but it is for the FDA and the drug industry..

":>) JL