A couple of points I think that were missed in the commentary to date.
1. The company clearly states that they will be submitting the second part of their application to the TGA in the first half of calendar 2022. They do not say that the TGA will make a decision within that period. My understanding is that in normal times the TGA attempts to make a decision within 80 business days of the second part of an application being made which likely takes the TGA decision on ColoSTAT into the second half of calendar 2022.
2. On better news, whilst the Study 7 results are not as good as the Study 6 results they still are enough to meet the draft criteria released by the US Centers for Medicare and Medicaid Services which released a draft decision outlining the criteria for the reimbursement of current and future blood-based colorectal cancer screening tests. They require that tests must demonstrate both sensitivity greater than or equal to 74 percent and specificity greater than or equal to 90 percent. The Study 7 results are 81% sensitivity and a specificity of 91%. I had thought that the first contracts would come from the EU but I am fairly certain they recently indicated that first contracts may come from the US.
RHY Price at posting:
$1.76 Sentiment: Hold Disclosure: Held
