IRX (ASX) Ann: Ethics Approval for Phase 1 CRPS

Originally posted by djwally: ↑

This is an excellent question as it really highlights the disconnect between the company's progress and the current market valuation.

You are completely correct in asserting that many company's run trials without engaging with the regulatory authorities. This is often to create "good news" as it often represents an opportunity to raise further capital at an elevated share price. But the trial results do not necessarily get the company any closer to a drug approval.

IRX is quite the opposite and of course they are operating exactly from the IHL playbook. They look for opportunities for an accelerated path to a New Drug Approval (NDA) - a 505(b)(2) pathway. The idea is that there is a fast-tracked trial and approval process because there is already considerable literature that can be drawn upon. They also pick conditions that don't require really long trials. e.g. panic disorder is a condition that can be assessed in a quick short trial. Its all designed around a short timeframe through to an NDA.

Their model is to run trials in Australia for as long as possible due to the excellent regulatory environment here around CBD/THC trials and research rebate support programs (they can get 43% of the costs covered by the Australian government). So up to and including the Phase 2 trials. But importantly they do this in complete communication with the FDA (pre-IND meeting) so that the goal is basically to design trials so all the results will feed into an IND application for a pivotal (Phase 3) trial in the US. FDA approval in the US is really the holy grail as it then flows to easy approvals elsewhere.

Now to your question. A positive Phase 2 trial is often a milestone that will garner significant interest for a takeover. To have a successful trial and application package that enables an IND to be approved by FDA and an IND opened means the odds of an NDA approval jump very significantly. From a risk reward point of view it is an often targeted milestone to take out a junior. From what i understand a successful Phase 2 trial for either PD or CPRS could set a bidding war in place that could see a valuation certainly in the many $100s of millions and probably more like a billion. I know that seems a bit unbelievable from here but i feel that his is actually what is on the cards and its really 9 months away.

that is my honest assessment and have been loading accordingly. However until this overhang is cleared, we are going nowhere SP wise i suspect

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Well i know old mate @ma420 took pot-shots at me for daring to suggest we could easily get in the hundreds of millions and even $1B MC with positive readout from our Phase 2 trials. Well here is some evidence for my statements. Some of you may have just seen this news below

https://www.merck.com/news/merck-strengthens-immunology-pipeline-with-acquisition-of-prometheus-biosciences-inc/

Prometheus have a promising drug PRA023 that has been through Phase 2 trials and gotten decent results. Crohn's disease. Well, prior to them getting to their Phase 3 pivotal trial, Merck have just taken them out for $10.8 Billion USD!!

Now we are about to enrol patients in a Phase 1 trial next month for Pain and a Phase 2 trial a month or so later for Panic Disorder. Both have huge addressable markets.

I stand by my comments that positive Phase 2 results from either of these will see our MC as i forecast.

Let the trials begin...

@Pinky789 sorry not to reply direct to you but i thought it was relevant back on this original thread

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Ann: Ethics Approval for Phase 1 CRPS, page-18

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