Mike:
That is good news. I would assume expansion would require a re-certification, but I don't know how long this process would take (6+ months?).
With so little news on the manufacturing/marketing front, I do start to wonder about accepting a buyout (Teva? Purdue?), but that wouldn't likely happen until FDA approval.
For comparison, ELTP signed a marketing agreement over a year ago for ELT-200 (which recently received a CRL from the FDA).
ELTP also signed a contract manufacturing agreement over 3 years ago, but that agreement included up to 12 generic products.