Regarding FDA. Technically, FDA should review and respond within 60 days after submission due to fast track and QIDP designations. Fast track allows for ongoing submissions of information as obtained throughout the trial process which allows for expedited review. Instead of everything at once, info is steadily flowing. Now, has CRMD been submitting info early? don't know. I think the whole 60 days is possible but unlikely. The info is not just on the 28 events, it's on all 700 patients involved along with prior trials. It's a tedious process. It will probably take just as long or longer just to submit to the FDA. And they won't submit anything until they meet with the FDA and review info. They won't submit unless they are 100% sure of approval. And just scheduling these meetings takes time. I may just be tempering expectations, but I think we got till 2019 before approval. Still, just a PR about filling an NDA will pop the PPS. Good luck to you buddy. Remember, these are just my opinions.
Oh, and lawsuit doesn't look so good so far....but CRMD has no money to fight this in court which has been a huge issue. BP would spend the money to win this suite imo. Good luck!
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