There is more risk than just India. These small Biotechs hide bad things from investors but need to give it all to the FDA. A surprise CRL that details concerns that were previously unknown is the norm.
Because Linjeta is formulated from insulin is the only factor reducing Biodel's probability of a CRL. If this was a brand new formulation then there'd be zero doubt the FDA would ask for a re-study for Type 1.
JonofDublins original point should not be missed-as usual, his position is well thought out- FDA accepted the data though they were short of staff and perpetually behind- they were not looking for something to do with time- that really does mean something-once again, this will not be a safety issue which is the reason for the vast majority of phase 3 denials- Even if you think this has an 80% chance of a worst case scenario CRL the upside is tremendous as an option play or long term hold-recall how hgsi ppi was gutted just b4 approval- This is like going to vegas and being offered 2 to 1 odds in blackjack- notice the time spent here by bashers and buy- then parley your earnings on ARDM