Agreed about the CRL, but what about the 483, what about the communications leading up to the CRL? Shouldn't the FDA, rather than being opaque, be as transparent as possible in their requirements, especially when dealing with cancer treatment?
In my opinion, I'm beginning to see 2 groups of people on this board:
Group A - I'll call the, isn't the government really nice when they GIVE me a tax break. They are very
benevolent and gracious.
Group B - The government works for me with the tax money I EARNED and I expect them not to waste it.
In regards to FDA vs. IMMU management.
Group A - I'm a stockholder and if the FDA says IMMU didn't do enough then I blame management. I
essentially hired management with my Gold vs. White vote and I chose to buy and hold
the stock. Even though we have evidence that an enormous amount of work was being done
onsite in response to the 483, don't blame the FDA because they are beyond contempt, they
provide information as they deem fit because they are the FDA.
And please, don't anyone get them mad at us.
I blame management until proven otherwise.
Group B - I am a member. We didn't elect members of the FDA or have input on their hiring, rules of
governance, authority, etc. We have no control or visibility into who they are, competence,
integrity, etc., even though they are our employees. They work for us at our expense, for overall
benefit of U.S. citizens. Yet, as their employers we have no oversight, no visibility into their
decisions. With all the evidence presented, with onsite verification of work in progress by a
poster on this board, I want and expect detailed answers from the FDA because they work for
me. I blame FDA until proven otherwise. |
