The drug doesn't work in India for the reasons unknown to people - there are several possible reasons , but one of them is it doesn't work. The FDA is certain to reject the approval. The best scenario will be FDA asks for another trial, and the drug fails after so much time so that insiders can sell their shrs on time.
I think you have a couple of key measurements that are published. the P value must meet the criteria and based on the company docuements I have read, that works fine.
The next item is the 80 people in India. The FDA accepted the NDA. That is a positive, but always assume the worst. If they don't accept the data, we have to enroll 80 more people and do a supplementary trial. They have the money to last through it and the trial would not take that long with the protocols in place.
The best thing to do is contact the company. I did, I posted their response months ago and I look forward to the run. You can also buy and bail before the announcment and just get the run up with no risk.
I think they are 50/50 at best. They are trying to exclude the results of India from their trial results. FDA doesn't like post hoc analysis to justify approval. There is a good reason this is a sub $100 million market cap stock.