NATHAN SAYS:
1)) Execution is a problem for Clarity, they haven't shown great execution capabilities to date, what makes you think they can execute in US market well?
2) Clarity has been around for around 15 years, spending other people's money and has not one product in market. Enough said.
This is not a defence of Clarity, but Nathan - please do some research on
how long it takes to bring a drug to market, before using that as a measure of competence or lack of. I just did for you - here is what I found;
Stage 1: Discovery and Preclinical Research (
3–6 years)
Stage 2: Clinical Trials (
6–8 years)
- Phase I (1–2 years)
- Phase II (2–3 years)
- Phase III (3–5 years) - This is the stage where CLARIFY and the soon to begin AMPLIFY Diagnostic Trials are at.
Stage 3: Regulatory Review and Approval (1–2 years)
So, according to this timeline, it takes
9 to 14 years to get from discovery to end of Stage 3.
The QUESTION that Clarity SH's may ask back is: How long did our wonderful Telix take to bring Illuccix to market?
Answer: Just 6 years!
How? Telix did not have the early stages such as discovery or Phases 1 and 2, or even any large Phase 3. They skipped all of those steps earlier steps by utilizing a regulatory pathway that allows companies to rely on existing clinical data for the active ingredient. 68Ga-PSMA-11 is a generic product that academics have researched extensively before.
(20min delay)