This is wrong. I have a PhD in organic chemistry. These isomers structural isomers not stereoisomers. As such, they cannot be enantiomers and do not fall under the guidelines he sites. Having said that, I will tell you with absolute certainty that if the FDA follows it's own rules to the "T", then we will not get NCE. However, in the spirit of supporting innovation and therefore promoting it, I believe the FDA is strongly considering making an exception in this case given the completely different clinical profile of this isolated drug compared the the mixture (Lovaza).
nice to hear from a voice of reason after a long hiatus. tell me drugmaker2005; what do you think of my recent post "The De Facto Informative Thread to quell the paid,misaligned Bashers/Shorts"; does the data provided sit right with your thesis?
Drugmaker's comments make more sense to me. Vascepa is an exception that FDA is making. I do agree that it's in line with the strategic goal of NCE even though it may or may not meet the verbatim definition of NCE. But NCE definition is just a mean to the end. It's the end that is more important - encourage/protect innovation and clinical data.