ABT did not bring up its contractual dispute with DEPO until JUST BEFORE APPROVAL.
The reason for that is simple: Earlier during the NDA review, ABT was not certain about the FDA APPROVAL of DM-1796 and therefore, it did not bring up the contract dispute because there was a chance of a negative FDA decision, which would have nullified the contract.
But NOW, since ABT is quite CERTAIN of FDA APPROVAL, it could no longer delay the contractual dispute.
According to DEPO's CEO, DM-1796 received its ORPHAN DRUG STATUS because of its SIGNIFICANTLY SUPERIOR SAFETY PROFILE as compared to the current PHN drug (immediate release gabapentin). And these are the EXACT SAME ATTRIBUTES of DM-1796 that the FDA uses for APPROVAL.
The fact that DM-1796 regimen is a single daily tablet (as opposed to multiple daily pills for IR gabapentin) is the ICING on the CAKE.
probably right but that still does not take away the new uncertainty of whats going to happen. Lets say approval is a given. Well then everything else is not so sure and thats where this sits right now. If ABT comes back and says they will stand behind DEPO it could bounce back but right now DEPO just had the rug pulled from under them and ABT knows this and is trying to crush depo into submission.
ABT wants to renegotiate, which means it probably wants the MUCH MORE LUCRATIVE Serada deal.
As for DM-1796, both ABT and DEPO seem to be convinced of FDA APPROVAL as well as a very FAVORABLE LABEL.
And then there is the ORPHAN DRUG STAUS of DM-1796, which CP said was awarded because of the SUPERIOR SAFETY PROFILE of DM-1796. The 7-year marketing exclusivity that comes with the orphan drug status will make it much easier to grab RAPIDLY a majority MARKET SHARE.