Actually Ceth and Ketek are marginally different base compounds. I am not a scientist and cannot fully explain the differences but it has something to do with the way in which the molecules are bound together if I remember the reading correctly. IR claims that this difference is an essential element in the better safety profile.
A Walmart shopper was killed: Close all the Walmarts. A soldier was killed in Iraq: Send all the troops home and stop the fight against terriosm. A police office on duty was shot and killed: Close the police station, it's too dangereous. Two people died in a head-on collision: Ban all driving.
In most cases you are absolutely right. But, this one is a little different. The biggest question with Cethromycin was the non-inferiority. It seems to be OK and we all know the phase III results and the safety profile that was generated along with the phase III results show the drug works AND is safe. This took a boatload of risk out of the equation no matter what you think of ADLS as a company.
"It seems to be OK and we all know the phase III results and the safety profile that was generated along with the phase III results show the drug works AND is safe."
hmmmm, good point - it SEEMS to be ok......its SAFE and EFFECTIVE.....what is it dalong?
if the PhIII data shows it's safe and effective, it is OK, right doctor?
if it SEEMS to be ok, what are the liabilities?
if it's safe and effective, why isn't it ok?
what the heck are you trying to say?
I'll bet you, dalong, the FDA evaluation will be heavily influenced by the ketek/ketolide precedent, and will weigh down ceth with an extensive PhIV - after all, it SEEMS to be OK, but it may not be ok?
Wait, you then say it's safe and effective - do you agree w/ the PhIII data's results or not?
Frankly dude, the 'it seems to be ok' doesn't mean junk. So by your logic, since the PhIII say it's safe and effective, approval is a dunk shot? right? How bout we dose you up? AFter all, never mind it's the only other ketolide out there, and ketek was after all, seemed ok until PhIV.