If a company doesn't tell investors they filed, they'll also never tell if their filing is returned for changes, even if this happens several times and takes many months, nothing will be said. When the filing is accepted, that's when investors will be told the filing was accepted. We saw how long the MIA took because we were told of it being accepted, we know they inspected at least a few times, so clearly some changes were required.
If at the time a company files with the regulator problems are immediately seen, I believe they send the filing back and request changes rather than rejecting the submission after evaluating it and requiring a new submission. Once the filing has been accepted, then they have to review what's there and if approval cannot be made because of problems they must be fixed and a new submission made setting up a new PDUFA date 6 months later. It's far better to resolve problems before the formal submission is accepted.
I really don't think investors have any idea of how much interaction occurs between companies and the regulators. Years ago in the case of Erbitux being delayed by the FDA, but IMCL misleading BMY about all being good before the rejection, it became clear after the rejection that IMCL had totally misrepresented the communications between them and the regulator. At the time the regulator couldn't comment on such misrepresentations, but that changed. I don't believe any company must say they've conferred with the regulators, but if they do, if what they say isn't a proper representation of what the regulator said the regulator is empowered to speak up. Most companies don't speak about it at all, and they're all unlikely to ever criticize the regulator as it's like going to court and criticizing the judge. I'd love to hear some of their comments in private, but I suspect they'd be X-rated.
Gary
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