I could be mistaken, but I believe that if a filing is rejected for changes, most companies would make the change, resubmit it, and say nothing until it was accepted. I don't know that most companies announce submission, but even if they do, when acceptance is delayed investors just assume that some changes are being made and wait to hear of an acceptance. Of course it would be very different if a complete rejection was occurring, but I believe that would be very rare if the company and regulator were working together at all during the trial.
In the case where IMCL's BLA was rejected, and Martha Stewart and the CEO were jailed for insider trading before announcing that additional trials were being required. IMCL knew of the FDA's problems with the trial, but didn't have to divulge it until the FDA officially rejected them. During that time they sold BMY on partnering Erbitux with assurances that things were well with the FDA. At that time the FDA's hands were tied, they couldn't criticize their views being improperly stated. After this case the rules were changed and if the FDA's position was misrepresented, they could say so.
If they ever wanted to make a Biotech version of the movie "The Sting" all they'd have to do is do a picture of what IMCL did to BMY in the partnership for Erbitux. Of course in the end it became a blockbuster drug, so it took longer than BMY figured, but ultimately it was very profitable.
Gary
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