Replies to post #113966 on Biotech Values

[RockRat]

>>could t-enox be not Lupenox per se, but a product from ItalFarmaco that is essentially unchanged from the product ItalFarmaco licensed to Lupin for sale in India as Lupenox? <<

I don not see this as a material difference from the FDA's viewpoint. So, on to

>>If not, could you be wrong in your analysis?<<

My analysis has two parts, which I'll summarize as 1) It would be almost impossible to derive true, substitutable enoxaprin from Lupenox or something like it, and 2) I have serious doubts the FDA would consider Lupenox or something like it for this long without rejecting it.

No, I do not have direct evidence T-enox isn't Lupenox. I'd give 1) a probability of 95%, and 2) a probability of 65% for a composite probability of ~62% my analysis is correct.

But that does not consider my belief that this is a different product, the production of which ItalFarmaco may well be assisting, but which at the very least has a molecular weight much closer to branded enoxaparin than does Lupenox or something like it Lupenox.

I don't have enough data to calculate risk/reward on that belief.

I have noted before that ItalFarmaco's IP in this area has to do with filtering heparin derivatives, not depolymerizing heparin. FWIW.

Regards, RockRat