....has a solid chance of approval in the back half of the year,"......
I thought approval would not happen until 2014, am I wrong or is Cramer wrong? TIA
"I think their drug Tedizolid, for MRSA skin infections, has a solid chance for approval in the back half of the year," Cramer said. "The company has $100 million in cash to fund commercial operations, and Tedizolid could garner peak sales of $800 million. So I favor the risk reward here, but please use price limits. Biotech investing is tricky, especially within these tiny micro caps."
If im not mistaken, the first catalyst would be the NDA submission which is expected by Q3-Q4. I believe Tedizolid is on the fast track which means FDA has 30-60 days to reply for approval which would be the second catalyst.
Agree with fast tracking on FDA under the GAINS act and possibly a faster NDA submission under an improved PDUFA V review process, this all could happen within 6 months? With Bayer behind the helm they probably had a head start wrt to planning the pre submission process, and should move through the required steps quickly. With a PDUFA V communication review midway in the submission process it will be telling how fast this may take. Usually happens in month 5 of the 10 month process but it could be less given the newer expedition process. Check with CDER 21st Century Review Process.