> CRL's often don't give the level of detail needed for a company to map out the specifics steps needed to gain approval.
So you're saying the FDA doesn't provide details needed for a company to bring a life saving drug to market?
So FDA prefers to be opaque, in order for a company like IMMU to spends millions, spends months responding to an opaque set of requirements, shooting in the dark at that opaque set of requirements and in the end find out they didn't adequately read between the opaque lines?
So you're saying it's in the FDAs DNA to play God? To claim they are looking out for patient interest by
saying, we'll determine your quality of life while you slowly die. To tell someone dying of cancer, we
won't allow you to have a drug which already exists and will improve your quality of life, give you more time
with your family and possibly save your life because when IMMU tries, in the future, to manufacture the same drug they've already produced, there is a possibility that a chiller, a drainage issue, a documentation issue, which has never affected the previous efficacy and safety of the drug, could in theory cause harm to you just before you die.
Even though it's IMMU which has been in existence for over 30 years, performing ALL the research, obtaining funding, experts, etc. Companies (people) do ALL the work, take all the risk........but the FDA bears no responsibility to communicate clearly to help bring a cancer drug to market? |
