hpv genotyping trial design, page-2

a2g - congratulations, your seventh post on HC and your seventh post on GBI.

You really must have quite a deep interest in the company!

It is a very interesting journal article that you post, and one that is generally very supportive of a genotyping test being used as the primary cervical screening method in due course. Potentially a huge market.

We know that the current clinical study being undertaken by GBI is not on 6,700 patients, but instead on circa 900.

However, given that this population is a triage population rather than a screening population, I would expect that it would contain many more than 134 CIN2+ specimens. i am not sure what this would do to your assertions re population size - more CIN2+, less absolute number of specimens. Maybe you could elaborate??

I recall that back in June GBI also stated that it was going to be doing a couple of further studies, one on a screening population of samples that RWH has in the fridge. Another to be undertaken on an American screening population - don't know where these samples are coming from.

I don't recall whether sizes of these studies were disclosed, but presumably a few thousand samples in these combined?? Which should get you much closer to the 6,700 in aggregate.

A couple of further points:

a) We all know that GBI is not doing a study that would qualify PapType for FDA registration. To do so would cost tens of millions. Nobody has ever pretended otherwise.

b) there is a presumption by a couple of the self proclaimed experts on this thread - you and liqcrisis - that GBI is a mickey mouse operation and doesn't really know what it is doing. This may be the case, but the WEHI pedigree of the science is pretty good and the RWH is a solid partner to have on the clinical studies - they are a WHO reference site for HPV and pretty well versed in the area.

c) as for your assertions regarding what potential partners would think of a clinical study with certain clinical parameters. . . . well, you are guessing. You are essentially asserting that anything less than a full FDA study is going to be insufficient to attract any interest. If GBI had a completed FDA study it would be worth something approaching $500 million. . . . just like Third Wave.

Let's wait and see. Only time will tell.