It got approval March 2013 (so only one year out) so could technically process tests from then and probably was (ie. user trials etc)
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Some good new information in the Capital Raising Presentation (click here to view the PDF).
These tidbits caught my eye and contained something I didn't know, but there is much more in the document, so do your own research:
- Australia: User Program underway in Queensland to evaluate replacement of ultrasound in a clinical setting with Cxbladder.
- Spain: Licensed partner Oryzon promoting Cxbladder for recurrence monitoring and targeting sales into public hospital systems early 2014.
- Clinical validation: Cxbladder has been validated on 178 patients, recruited in a blinded “User Performance” study from two New Zealand DHB sites (Unpublished as at 23 October 2013). The performance of Cxbladder in this validation setting shows a sensitivity of 90% at a specificity of 75%. Cxbladder has been effectively validated and has an equivalent performance to that seen in the published clinical study (Journal of Urology, September 2012).
- Product Development: Pacific Edge’s on-going development programme includes clinical and User Programmes to validate Cxbladdertriage, a new product positioned to enable clinicians to segregate patients who have presented to the clinician with haematuria, who do not have bladder cancer. Launch 2014 Q2.
- Product Development: Another of the Company’s products in late-stage development and validation is Cxbladderpredict, which will enable clinicians to determine the severity of bladder cancer disease and enable them to non-invasively segregate superficial tumours from invasive tumours. Launch 2014 Q4.
- Priorities in the US: Pacific Edge anticipates continuing and concluding negotiations in earnest with Medicare and Medicaid in 2014. Approximately 115 million U.S. citizens are covered by Medicare and Medicaid.
- First Commercial Sales: PED USA’s sales force was on the ground at the start of July, seeking to build relationships with targeted LUG practices. Several of these have now successfully completed their User Programmes and have made their first commercial orders. The first commercially sold tests, processing through the Hershey laboratory, are expected to be monetised in the next few weeks.
:t_up:
I don't get it, that media story got the dates wrong, but they don't just make stuff up, am sure someone told them something and they screwed up. Or someone let something slip that March 14 was an important date and they got the reason why wrong. Something smells fishy anyway...
Bobbles, it could be as simple as the reporter's Source mentioning that "approvals were obtained in March" which was wrongly interpreted as "approvals will be obtained in March". Investigative journalism here in this country that we both love is afterall a bit sub-standard.
I liked the bit about being used for product development and product launches. It sounds very definite. Not if but when. The only problem was it wasn't attributed to anyone so it could easily be just column stuffing.
Yep, most likely they screwed something up like that, but usually dates are the things they get right and repeat to ensure they get it right. In that case it probably means March next year is a big date for something and they stuffed up the reason why. Hopefully there will be a correction or retraction or something from either the press or management.