re: Ann: Results of Major Clinical Study-Gene... Yes a solid announcement and great to see this progress.
I imagine that a partnering deal is still 4-8 weeks away and expect TGA approval next week.
I note that they have only released the false negative numbers - mind you a low false negative rate is the most important figure from a commercial and regulatory perspective (ie. its ramifications on NPV and sensitivity as the nature of HPV and cervical cancer means that these type of tests usually all generate solid true negative results).
Cervista also has a control incorported into it and was a key point of difference between that and HC2 when Hologic announced that they would buy Thirdwave for US$580m.
This data set bodes very very well for the proposed screening study later this year and by its very nature I would expect the data from the screening study to be even better than this data from a false negative perspective. The question will be what will the variance be between PapType and HC2 in the screening study. Intuitively, I would expect the variance to narrow.
Onwards and upwards from here and would expect the CEO to undertake a roadshow over the next week to market these results and would expect that they have already been marketed to potential partners.
With a license to manfacture granted by the TGA next week, CE mark should be achieved within 8 weeks and hence GBI should then be able to push PapType product through the Sonic Europe channel ASAP thereafter.
A decent upfront license fee from a partnering deal should also mean that GBI does not have to raise additional capital again before coming cashflow positive (touch wood)
Rgds
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re: Ann: Results of Major Clinical Study-Gene... Yes a solid...
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