Re: MNTA
>>Generic Fragmin is clearly not a big-ticket item, but I would argue that it represents almost-free money. Hence, “reprioritized” does not necessarily mean dead, IMO.
Assume DD is right and FDA accepts MNTA's characterization capacity and ability to mfg/duplicate allowing an easy route to approval.
An additional concern would be that building/mfg/duplicating a complex mixture when done by brute force would be accomplished at a significantly higher cost than the branded. If so that would further reduce the "priority" which MNTA would accord it.
ij
There are times when rules and precedents cannot be broken; others when they cannot be adhered to with safety. (Thomas Joplin)