Hi everyone,
I'm back now that my initial shock has settled, not selling, holding. My view is that the product is fundamentally revolutionary and will get there in the end. Of course, we would all like things to unfold seamlessly, however, this is rarely the case when there is so much at stake (public health).
I had a speed read of the Therapeutic Goods Act 1989
https://www.legislation.gov.au/Details/C2021C00376
Batch testing is referred to a lot in the Act, but only devices already on the register are covered in terms of the records they need to keep for each batch. I believe the TGA want absolutely 100% assurance that this thing is perfect so they have sent Rhythm back to prove it. I believe Rhythm will succeed the second time around.
I don't agree with any conspiracy theories, and I don't care how rich the directors are etc. I do believe that the Rhythm team will report to investors accurately and professionally when they have meaningful information. It's only been a week!
Perhaps the company would have been in a stronger position when negotiating financial deals with overseas partners if they had achieved TGA approval., which might be why there aren't any as yet. Potential partners may well have the upper hand in negotiations at this point, especially if they are aware that the company is pretty keen to secure a deal quickly!
It seems to me that it's not too difficult to form a partnership with a US CLIA lab, especially if the whacky companies that Barano keeps throwing up are anything to go by.
I'm confident that with some time, Rhythm management will navigate forwards. It is disruptive technology after all, not for the faint-hearted. I'm happy to wait a year or two for a 10-20 bagger!
All IMHO
