Having followed other companies that the FDA has turned down, one of the big things I am seeing as a reson for turning the drug down is the concern the the FDA has regarding the inspection of a plant involved in the development of the medicine. I realize that BAYER is a player here, but is this a concern? I feel we are good to go on safety and efficacy issues.
I'm sorry. Typo. Not "the" drug as in Trius's drug. I am referring to drug companies in general. That is a reason I have seen for some drugs not being approved. I don't see any other negatives with TSRX so wanted to see what others thoughts were considering they don't have an approved product, yet.
Herky: Well when it comes to the regulatory phase, ya got to learn the processes and terms here since its coming for ya next year! People here should start to study up on the submission process as you are heading towards it in the next few months!
The FDA has a mechanism to outright reject drugs, but most of the time they don;t reject them, they put them in time out and its called a Complete Response Letter (CRL). it doesn;t mean your drug has been rejected--it means your submission is deficient over something!
That something could mean anything from doing more study work on the clinical side over safety and efficacy (not likely here IMO), but it also could be a simple as wanting more pre-clinical data because your tox studies are too old, or CMC issues which could mean manufacturing defficiencies off a regulatory 483 audit of your facility or contract facility before the.decision (the agency will audit the facility), or a CRL could be ovewr even simple labeling delays. No CRL is good as it dalays, but there are degrees of CRLs too!
CRL: Doesn;t mean your submission is rejected, it means ya got more work to do or data to provide in some area---you become in progress! First TSRX must put this very large NDA together and then submit. And then there is a 30-60 day window where the agency accepts the submission and gives it a PDUFA ruling date or kicks it back to the Sponsor saying the content of the submission is incomplete. Once accepted, then the agency looks in depth at the data using either a short review cycle and/or a longer cycle for review. That affects how long you wait for the ultimate decision.
Thats a start---I recommend a trip into the FDA website and some research on the regulatory process while ya wait!