TGA resubmission seems to be based on additional factors in regard to the product being used for national screening program which is what their main selling point was.

Also more importantly we do not know how much RHY is earning in NZ despite receiving approval therw (correct me if I'm wrong)

Either way a disappointment for holders.

Finally found a recorded webinar from Hotcopper

https://mstfinancial-au.zoom.us/rec/play/BE4rrFKUPqO6Ob477AowlGCEmV5WrYvIMc-pjM-8bR19_oz_NxcwefY78iE58378OUxum6_S7Y2yEUcg.BINiSVzlChd1n0Vq?startTime=1670281207000

This is the latest update from Gilbert. Caused a share price spike in the last few days but has now settled back down. Seemed to be talking up the approval but also seemed to struggle as to what he should or shouldn't disclose during the call.

Also Guardant released their trial results for their DNA blood based test and it came back worse than expected.

https://www.reuters.com/business/healthcare-pharmaceuticals/guardant-heath-dna-blood-test-detects-83-colorectal-cancers-trial-2022-12-15

RHY gives an update saying that they are expecting TGA approval soon and that correspondence has been positive

Plus there were a few other updates to reassure some shareholders

Unfortunately I took the chance to exit my small holdings when it popped above $1.02 after listening to "the call" review by Ausbiz.

Ausbiz thinks there are too many unknowns after receiving approvals and they ramp up production which I think may take months. Biggest concern is whether there will be sales given the landscape around cancer treatments and diagnostics is rapidly evolving.

Hoping RHY proves everyone wrong though.

Still on my watchlist though.

As usual I didn't follow through when the price fell below support at 1.06. But also I was waiting for my excised options to arrive in my account.

Holders appear to be frustrated by the lack of progress. Given TGA approval timeframe is up to a max of 8.5 months, I'm surprised they promised they will get approval in 3-6 months which hasn't happened. This guidance will probably haunt RHY management for a while. Only way out now is they can convince the critics and investors Colostat will sell like hotcakes.

Also surprised the CEO was working for Seqiris and MVP before so would have expected better communication.

Main thing for any company including RHY is to underpromise and overdeliver, not overpromise and underdeliver and the share price is underperforming the wider market because of this.

In the meantime I'll take this as a lesson to do my own DD into the industry particularly with the TGA approval process.

As an aside, it would be good to invite the CEO of RHY for a chat with Strawman members. Unfortunately I could not find any transcripts/recordings of RHY AGMs and conferences on file.

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RHY approved to sell their ColoSTAT test in New Zealand. No word yet on when it receives TGA approval. I think the lack of update on TGA and FDA approval is a bit of frustration for shareholders including myself. But maybe a small positive although we don't know how big the market could be in NZ.

Having said that there had been some options conversions which gives RHY more cash but also puts pressure on the share price

As always, committing the proverbial sin of TAM from the recent Bell Potter healthcare conference. No word on the important TGA approval which also could be hurting the share price. Line on the sand is $1.05 hit in June.

Commentary below from this weeks announcement:

Regulatory Approval in New Zealand

Medsafe is the New Zealand Medicines and Medical Devices Safety Authority. It is a business unit of the Ministry of Health and is the authority responsible for the regulation of therapeutic products in New Zealand.

As a manufacturer of ColoSTAT®, Rhythm has registered with Medsafe and listed ColoSTAT® to its Web Assisted Notification of Devices (WAND) database.

Rhythm has completed the process to achieve authorisation as a manufacturer of ColoSTAT® in New Zealand. The regulatory milestone means that the Company can now:

▪ market ColoSTAT® for sale in New Zealand;

▪ progress pre-sales activities immediately; and

▪ commence partnership discussions.

Commenting on the regulatory milestone, Rhythm CEO and Managing Director, Glenn Gilbert, said:

“Rhythm is pleased to expand its international regulatory approval footprint into New Zealand which enables the Company to commence marketing and sales activities for ColoSTAT®.Bowel cancer is the second highest cause of cancer death in New Zealand and a growing issue with 1 in 10 now diagnosed under the age of 50.ColoSTAT® is a simple blood test which has the potential to make a material impact on health outcomes through mass screening for higher participation to achieve early diagnosis. We look forward to working with the Ministry of Health’s National Screening Unit to enhance New Zealand’s National Bowel Screening Programme

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A great example of the use (and abuse) of TAM (Total Addressable Market) from Rhythm's presentation

Currently at 300m market cap. So it seems undervalued against the TAM given above...

But if we take into account Rhythm is targeting for commercialisation in Australia which is only 350m once approved by the TGA. So in actual fact the share price is around fair value for the moment.

Also, they already have CE mark for Europe but we don't know the timetable for first revenue over there so I don't think we can factor this in at the moment.

Last few days the price rallied from $1.20 on no news (the ex-price of unlisted options).

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