In the quarterly the glaring omission for me from the list of what can be expected for the June quarter is any reference to the TGA process. Whatever was raised in the 26 page response by the TGA regarding the flaws in Rhythm's initial application seems not easily or at least quickly rectified. Other than a vague reference to an issue with the test kits reliability the effective rejection of the Colostat application by the TGA remains a black box.
The surprising inclusion to the list of what can be expected for the June quarter is the idea of commercialisation / partnering agreements with third parties. "Third parties" suggest that Rhythm is not working directly with the government agencies that provide mass testing for bowel cancer. Anyway, any sort of formal agreement at all, whether it be with third parties or government providers, would be a giant step forward, I think. Also surprising to see South Africa as one of the near-term targets, partly because of my ignorance whether South Africa is first world or third world jurisdiction in health matters.
This stock is running at about 25% of what the share price was when the company first applied to the TGA. In hindsight for the how many months - I think 9 or 10 months - that application was stuck with the TGA the company was transfixed like a roo in headlights. As I have suggested previously I think it became clear to the company in December last year that the application was in trouble and the reaction should have been more than Otto diversifying his portfolio, the founding director resigning and Glenn Gilbert releasing a powerpoint presentation. That GG as MD decided not to implement a Plan B back then is enough of a reason for him to leave the company. Going on this quarterly I am not convinced that Otto has yet come up with a Plan B.
As an aside I attempted to look into how the two abstracts about Colostat fit into the June meeting of the American Society of Clinical Oncology (ASCO). From what I can work out having the two abstracts available for people at the conference to read is a nothing burger. It is almost as if that one of the comments from the TGA was that the Colostat product has not been subjected to sufficient exposure and review and this is how Otto is attempting to address that criticism.
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