Knowing that most don't follow here but I will still post some thoughts

Just found that over 19m was spent for FDA approval possibly in the last few years.

But the crucial thing is in the last report 2.8m was spent and maybe 1.2m the year before

If you strip out the FDA expenses, Cyclopharm still isn't breakeven - perhaps 3m loss last FY and the same previous year.

This is the likely reason why there is still nervousness even after FDA approval

In addition, they still need to spend money for the US market launch even though they have 8.2m of inventory for that market. So there is about 20m allocated for the US market launch. In other words, I don't think CYC will be profitable until FY25 (hoping I'm wrong though). There was also the presso with the CR mentioned by accident that was retracted the same day last week!

Should have done more research before on why they are not breaking even with so many countries ex-US on board.

Hope CYC can become cashflow positive after US launch.

So despite the FDA news, this is more a wait and watch until we can see something meaningful in the financials.

Having said that, Bell potter increased the price target to 4.25. But looking at their track records, especially with CXL I don't think BP can be trusted

[held]

Cyclopharm finally receives the coveted FDA Approval for Technegas

No Trading Halt

Interesting. Does that mean Trading Halt going into FDA approval for other listed cos bad news?

Anyway patience has been rewarded. 180m potential opportunity level unlocked.

Next step is achieving the "Beyond PE" objective.

Wish I held more but always need to think about the potential for disappointment when you have binary outcomes.

[held]

Cyclopharm released their latest presentation. Expecting a response from FDA review around 29 September and much of the rally being driven towards that date.

Cyclopharm has been working on their CRL response for over a year after FDA had questions on their process last year.

A few points to support an investment case is that there is support from the Nuclear Medicine community in USA on Technogas and it is already being used and earning revenue globally ex-America.

So the FDA approval seems less binary than before.

But you never know with the FDA and there is still a chance FDA will issue a SECOND CRL. Can't remember who, but I did see FDA issue multiple CRLs in the past.

[held]

Not a big amount but at least the trend is positive.

Record revenue $15.3 million, up approximately 39% on pcp, including:

• Technegas TM revenues steady on pcp, at approximately $7.6 million
• Third-party distribution sales up approximately 116% on 1H 2022, to approximately $7.7 million.

Looks like the revenues flatten out in the 2nd half versus 1st half. So may expect growth to be not as much in 2H23.

[held]

Cyclopharm is a diagnostic imaging company specialising in lung diagnosis of PE or Pulmonary Embolism. Their main product is Technegas, an imaging agent that is breathed by the patient to get a picture of lung health and signs of PE.

Technegas is selling in over 60 countries except the US. But it is well regarded among the medical community in the US. They also want to look at other applications in monitoring COPD and other lung conditions.

However it is still waiting for FDA approval in the US and they have been making losses over the last few years while they make preparations to enter the US market and they were negatively impacted by the Covid pandemic.

In April 23, Cyclopharm submitted their answers to the CRL (Complete response letter) from the FDA on how they produce Technegas and is hoping they will get a positive decision back by Sept this year. This I believe is their only roadblock in pursuing their goal to use Technegas for other lung conditions.

The other point is they have paid a dividend despite having negative net income and retained earnings. See below

I'm not sure how that works, maybe someone here can answer that.

But they do have 20 million in cash and raised cash last year at 33 million presumably to scale up in US once they thought they get FDA approval last year which is now hopefully Sep 23.

Interesting company but a few flags here. Will be interesting once the review is complete and FDA grants approval this year.

One of my tax loss purchases and has held steady since I bought the dip.

[held]