Approvable and subpart H approval would both have the same effect. Either way, the product would have to wait until the current phase 4 study is finished before it could hit the shelves.
LJPC doesn't have the cash to manufacture and market the product on their own and would need a partner. No partner would take the risk and put up the cash until the phase 4 study was completed. Therefore, either way, we needed to wait till phase 4 is completed. There is no delay. If anything, this decision really makes everything more clear. We finish the phase 4 and if all goes well, the product hits the shelves.
Since the risk associated with marketing and manufacturing a drug which may eventually need to get pulled has now been eliminated and the only costs now are to complete the phase 4 study, I would expect to see a partnership deal come soon now. This announcement most likely will result in a quicker partner deal than if subpart h was granted. There is much less risk for a potential partner to assume now.
Since we already had a big selloff, maybe once the initial panic ends tomorrow morning, who knows, we may bounce back and finish green tomorrow.