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Sunday, May 25, 2008 9:29:40 PM
re: I guess they just didn't "feel" like it yet, huh?
Ha! :)
No, of course not.
You apparently don't understand how the phase I and phase II trials are set up.
The first possible meaningful ("warranted" as I said) update/report (in the current phase II trial which is what my post was about) will be (IMHO), to announce that the trial has passed the "Simon" or "two-stage" hurdle, meaning that the trial has achieved sufficient superiority, in the first 15 patients, over standard of care (which is chemo alone), to move into the second stage of the trial, (the additional 30-some patients).
I expect this to happen, and yes- hopefully soon!
I would love to hear as much detail as possible regarding specific numbers and classification of tumor response.
The least they have to say is that they "made it", and the trial will be treating the rest of the 31 patients.
(which would be great news in itself!).
More than that, it would be great to hear more details. We'll see. I'll be very happy to hear the simple fact that the Bavi/chemo combo has done well enough, (better than SOC!) to advance into the rest of the patient pool, but additionally, any further details would be icing on the cake as they say.
After that - is what I was referring to in my post (which you seem to have misunderstood due to ignorance of the trial protocols.)
To expalin:
Now that we are in this particular phase II trial,
This is NOT a dose escalation trial.
and NOT a "safety" trial.
You need to understand the trial parameters, and the defined endpoints of this phase II trial to understand why they now have the liberty to provide periodic updates as I was explaining previously.
It should be very exciting!
and I expect several updates with very nice info.
Personaly, I think we'll witness a major turning point in cancer therapy!
I also think that once the two Indian cancer trials get started, we'll be seeing, (due to having THREE similarly designed phase II cancer trials up and running), MANY "updates" - with very good info :)
j
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