Ann: Investor Conference Call, page-214

Currently unlisted. Proposed listing date: 4 SEPTEMBER 2024 #

First 214 Last

Share
Profile

Follow
TerribleTadpole

5,091 Posts.

2477

16/03/20

09:14

Post #: 43509171
Share

Originally posted by Southoz: ↑

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_kpS8cQ

When 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.

Expand

Nice to see you back. I've been wondering where you were.

I always valued your realism and incisive analyses.

RAP Price at posting: 8.7¢ Sentiment: Sell Disclosure: Held
3 Upvote

0 Great analysis

Reply

Top Stories

Week 40 Wrap: China's nonsensical stimmy hype wanes (shocking!); HotCopper's picks; oil & inflation

RCE

Recce eyes Indonesia for novel anti-infective as Indo-Aus ties grow stronger

COD

Coda Minerals (ASX:COD) enters rights issue to further exploration in South Australia

NTI

Neurotech knocked back by FDA as agency declares target condition not rare enough for special status

BCI

BCI reaches close of funding facility for salt-first part of Mardie project

ACW

Actinogen Medical ramps up Alzheimer’s treatment trials, targeting fast-track global approvals

WCN

White Cliff jumps 24% on 'bonanza grade' copper rock chips at Rae project, Canada

SLS

Solstice Minerals to ramp up drilling campaign at Yarri Gold Project

CKA

Cokal upgrades infrastructure for BBM ramp-up in Indonesia

BUX

Buxton projects new graphite province discovery at WA Narryer play

There are more pages in this discussion • 2 more messages in this thread...

First 214 Last

Add RAP (ASX) to my watchlist

Ann: Investor Conference Call, page-214

Top Stories

Week 40 Wrap: China's nonsensical stimmy hype wanes (shocking!); HotCopper's picks; oil & inflation

Recce eyes Indonesia for novel anti-infective as Indo-Aus ties grow stronger

Coda Minerals (ASX:COD) enters rights issue to further exploration in South Australia

Neurotech knocked back by FDA as agency declares target condition not rare enough for special status

BCI reaches close of funding facility for salt-first part of Mardie project

Actinogen Medical ramps up Alzheimer’s treatment trials, targeting fast-track global approvals

White Cliff jumps 24% on 'bonanza grade' copper rock chips at Rae project, Canada

Solstice Minerals to ramp up drilling campaign at Yarri Gold Project

Cokal upgrades infrastructure for BBM ramp-up in Indonesia

Buxton projects new graphite province discovery at WA Narryer play

Featured News