Commiserations to holders here.
As some posters here might recall I had a negative view on the approval – before it became a fashionable view.
https://hotcopper.com.au/threads/a-new-beginning.3861782/page-2378?post_id=37326431#.XmiX_kpS8cQWhen the second US trial results were released the share price halved. TK came out and claimed the results were in fact “outstanding” and it was investors who needed to become better educated about recognising good trial results.
https://unauthorised investment adv...ot-educated-enough-to-recognise-good-results/Well here presents RAP an opportunity to help educate investors.
Plenty of companies claim to have outstanding trial results. In fact they all do. And so the challenge is for investors to learn to be able to distinguish between those outstanding results that will lead to successful regulatory approvals and those that won’t.
What RAP need to do is to provide a paragraph setting out the reasons the FDA have stated for their rejection of the US trial results.
To help RAP they could use as a template the company announcement from Helius (the example AicP found) to investors explaining their failed de novo application.
“In reaching its conclusion, the Agency noted that it did not have sufficient information to discern the relative independent contributions of the PoNS Device and physical therapy on the improvements from baseline in the effectiveness endpoints observed in the Company’s clinical studies.”
The explanation Helius provided enables investors to understand the reason the FDA rejected their trial results.
Note the explanation should be made publicly. I think most people now have rumbled RAPs MO of feeding little snippets to selected people or through selected informal channels for what it is – a way to create a story – and avoid proper transparency.
