neo, "So if the IND committee presented the company with unexpected demands for additional testing, documentation, etc -- which I'm surmising from the way the PR was worded -- it'd be yet another example of poor decision-making by management, IMHO."
I agree with you about poor preparation by management if what you post is so. Even with FDA consultants, which is a good thing for CYGX, the FDA can be sticklers for the most inane stuff. Things that would make you go "what the???". VERY surprised that they have not hired a person in who either ran
a pharma/biotech or who was in the pharma business for years to help guide them too. Marshal, are you available???
It could come down to how things have been documented, logs, validation of methods and instruments, not enough information, testing insufficiencies (not enough raw data), SOPs, Job aids, etc, etc. Since many of the scientists employed by CYGX have worked in acedemia rather than in the pharmaceutical/biotech world and probably have little experience if any in CGMP I suspect that it is more along the lines of these things that may be holding the process up. If this is the case, I would love to ask MS
why they have not hired a pharmaceutical consultant familiar with what the FDA wants/needs. At the SHM I will be able to get a better feel for how they have or haven't prepared themselves for the FDA. It won't take long. Just a few questions.
That is why it is NOT a good idea to learn on the fly like MS
is paraphrased as saying. I sure hope he was not referring to the FDA when he said that. When it comes to this type of business, one cannot simply wing it. Now when it comes to criticizing managment for bumbling with this sort of thing I WILL LEVEL A BROADSIDE. No excuse for it. They should know better and if they don't know better, they had best get their collective butts in gear NOW. Not later. This part of the process is very serious business folks. Once the FDA sees discrepancies they sometimes knit pick at everything. Even to the point of missing countersignatures, dates, signatures, and the like.
