The Cellestis Board had concerns about the reasonableness of these materials and requested the Independent Expert to consider the CSAG letter, the documents referred to in the letter and any other material that it regarded as appropriate, and to prepare the Independent Expert’s Supplementary Report opining on the CSAG materials.Their primary objection to the CSAG valuation appears to be that
the assumption underpinning revenue growth in the CSAG Model is that as QuantiFERON-TB Gold In-Tube is a superior product to its competitors, Cellestis will be able to increase market share significantly over the next ten years. In our view, that assessment has not been borne out by the performance of Cellestis to date, which has seen Cellestis achieve a market share of approximately 5% despite the QuantiFERON technology being available in the market for more than seven years.Deloittes are inferring that QuantiFERON-TB Gold In-Tube has been marketed for seven years, an assumption which is flawed and misleading. By their own timeline QuantiFERON-TB Gold In-Tube was approved by the FDA in 2007. In an announcement to the ASX CEO Tony Radford said
With the In-Tube system the initial blood incubation needs virtually no labour and no set-up time. It makes a QFT test as simple as a routine antibody test, and extends the availability of QFT testing by streamlining the logistics, as its simple incubation process can be done almost anywhere. The FDA approval now allows our US customers to enjoy the cost-savings, and the quality result of In-Tube, as well as a better processing fit with hospitals and lab systems”.Clearly QuantiFERON-TB Gold In-Tube is a different QFT product.
Despite gaining FDA approval QuantiFERON-TB Gold In-Tube could not be properly marketed without the CDC guideline, which was released in 2010. In an announcement to the ASX Dr Antonino Catanzaro noted that
these guidelines encapsulate the enormous body of clinical evidence..The development of the QFT product has been a process culminating in the release of those CDC guidelines. This process, and the impact it has had on sales, was discussed by the Chairman Ron Pitcher at the 2010 Annual Report.
in the last decade we have seen multiple regulatory approvals, national guidelines and scientific papers endorsing the value of QuantiFERON® (QFT) emerge in every major nation of the world, with sales increasing accordingly.Deloittes simply do not understand the business.
