Re: Why didn't management do some phase 2's,....
in response to
by
posted on
Jun 18, 2019 08:01PM
"They could have confirmed the CVD with a 300 patient 12 month trial for quite a bit less and if it worked advance that one to a phase 3, and do 2 more of that size for CKD and CD. The stock price would have risen if the 1st phase 2 worked and they could easily raise funds."
The modern linear path in cardiovascular drug development is to first pass Phase 2 and 3 trials to prove that one can safely modify a risk factor (LDL-cholesterol, triglyceride, glucose, HDL-cholesterol, etc) and then proceed to a Phase 3 cardiovascular outcomes trial (CVOT). I am not aware of cardiovascular outcomes trials being run as Phase 2 trials. CVOTs are usually Phase 3, are very large and run for a long time. BETonMACE is a relatively small CVOT with 2400 patients and median dosing of 18-24 months.
Your proposal of a 300 patient, 12 month trial would only yield 300 patient years. To put into context, the combined ASSURE/SUSTAIN post-hoc was on ~500 patients treated for 6 month....about 250 patient years. I'm not sure your proposal of a 300 patient/1 year trial would have provided any more information than what they already had. It would have needed to be much larger and/or longer to provide the necessary number of events to provide the confidence and confirmation you are looking for.
BDAZ