lol ..... good on ya Maxgood to see you getting a bit fiery...

lol ..... good on ya Max

good to see you getting a bit fiery there


tanglewood says:
May 24, 2014 at 9:37 pm

Hi Dan,
I sent the following email to the FDA and included the reply you received from Peter French;
There is a bit of a controversy regarding who has set the eligibility criteria for participating in the clinical trial for Benitec Biopharma’s drug treatment for Hepatitis C.
Duke University Medical Center is performing the trial for the drug TT-034 but no one has been enrolled.
In a blog that I follow, a person posted a reply from Peter French, Managing Director and CEO, when questioned about the delay in dosing.
“
thank you for your email. There is apparently a myth being perpetrated on the blog sites that Benitec has control over the dosing process and patient selection. Presumably you believe them over the company. This is very unfortunate.

Here is a simple fact that you can pass on to the source of the information.
Benitec have no say in who gets dosed. None. The doctors at Duke run tests on the patients, then compare the results to the FDA mandated criteria and then decide to proceed or not. (NOTE The criteria are not ours. They are FDA’s and cannot be changed without a new submission). The Duke doctors do not ask us or seek our permission to dose. This is how ALL clinical trials are run. The sponsor cannot by law influence the clinical decision to dose or not to dose.
The duty of care and screening criteria are much higher for a first in man therapy hence the prolonged process.
We at Benitec eagerly are waiting for the dosing to begin too. It is in Duke’s hands as is the entire conduct of the trial from here on in.

I hope I have clarified your misunderstandings I strongly suggest you don’t read the blogs. I don’t.

Peter French”