So we received a CRL and returned it to the FDA for review which in turn they designated it to only require a class 1 resubmission and a two month return cycle. It seems fair to say only minor adjustments were needed and satisfied beings the first application was deemed good except for dose amount and next day residuls. Even those #s were within limits so what remained was a doseage fix which we know they accomplished. A class 1 r. doesn't even require a study by the advisory commitee and normally on involes a minor reanalyses of previously submitted data, and other comparitively minor information. I expect we here good news before Thursday the 24th!
If they were such minor details FDA wouldn't have rejected TWICE. So don't get too excited now. The fact is chances of approval is slim and that's why pps is $7 not $12 today. And also Class 1 resubmission means nothing. I have seen many drugs get rejected with Class 1 re-submission. I have been trading biotech's probably before you were born.
powertrader can you give me three examples of rejections in the last five years to current. Thank you in advance for the help. Please provide any such supporting links to coordinate your class 1 resubmissions to the outcomes of their failures. This should be easy as a veteran.
The 11 page re-submission contained some tables to be used in labeling (according to what I remember hearing). Remember, FDA only wanted facts and straight answers (no BS long explanations). My opinion is also that approval is coming (not really worried about when). JMHO