From what I gather regarding the P3, I am under th
Post# of 72446
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Posted On: 03/21/2019 1:52:21 PM
From what I gather regarding the P3, I am under the assumption that it will have an arm for both the high and low cisplatin treatments common today and a placebo arm.
Since there is data over the past years regarding patients receiving head and shoulder chemo-radiation, whether singly or in conjunction w/ one another, coming down with OM approximately 90% of the time, it makes me wonder just why the hell they bother with a placebo arm. A waste of time and money, not to mention the pain the patients only getting the placebo will have to endure, so what is the point?
I agree with an earlier post in that I don't see what the EMA could require in the P3 that the FDA didn't require. Should be a quick set up of protocol as a swish and spit regimen isn't that hard to administer and it is pretty easy to see if sores or other OM symptoms appear. Not like people are going to have severe negative reactions to the sachets.
Recruitment should be the first number of people that walk in the door for head/shoulder treatment as who would turn down a painless treatment that has no adverse side effects to date and could possibly lead to prevention of a deadly threat or at least severe pain? Anybody reading this that would turn down such an offer if going in for treatment?
They can high horse with medical BS all they want, this unnecessary time and bureaucratic lunacy really ticks me off. Makes me think someone is just trying to justify their jobs instead of getting things going.
Since there is data over the past years regarding patients receiving head and shoulder chemo-radiation, whether singly or in conjunction w/ one another, coming down with OM approximately 90% of the time, it makes me wonder just why the hell they bother with a placebo arm. A waste of time and money, not to mention the pain the patients only getting the placebo will have to endure, so what is the point?
I agree with an earlier post in that I don't see what the EMA could require in the P3 that the FDA didn't require. Should be a quick set up of protocol as a swish and spit regimen isn't that hard to administer and it is pretty easy to see if sores or other OM symptoms appear. Not like people are going to have severe negative reactions to the sachets.
Recruitment should be the first number of people that walk in the door for head/shoulder treatment as who would turn down a painless treatment that has no adverse side effects to date and could possibly lead to prevention of a deadly threat or at least severe pain? Anybody reading this that would turn down such an offer if going in for treatment?
They can high horse with medical BS all they want, this unnecessary time and bureaucratic lunacy really ticks me off. Makes me think someone is just trying to justify their jobs instead of getting things going.
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