all the new FDA requests just like many other companies have done in the past...
Other companies don't rely on 20 yr old ad hoc study data. Where the studies were flawed.
no reason to think pmcb cannot provide answers...clarifications...
There's every reason to believe Kenny the Mad Scientist won't be able to provide clarifications.
Minor example: A group of 5 patients in the first study were classified as Stage IV disease. Which means there is metastasis to distant organs. Yet the 5 were denoted as "Mx". Or insufficient information to determine whether metastasis was present. Therefore, what was the criteria for saying they were Stage IV? Or the patients with no distant metastasis (M0) being classified as Stage IV? Were they all instead really Stage II initially? Where one would expect a longer OS?
Minor example #2: What does tumor size of 50-125% of initial size, mean per "stable disease"? How can one have stable disease, if the tumor is 125% of the initial size? As having grown.
or test results like we have done in the past year or so
A SH can count on Kenny re-running all kinds of "tests". Maybe in Oct 2021, the FDA will require a new manufacturing run. Along with a PR pump repeat charade of GMP validation "tests". Just replay the past 3 yrs of PR pumps.
The Jewel of the Mind is Colored with the Hue of what it Imagines