Well-known member
Very interesting. Great find.

I'm no regulatory expert, but my reading of that is that one method to get the FDA allowing early access to treat patients is to "generate evidence of substrate reduction". CUV says one of the clinical objectives of
Scenesse in DNA repair is the "elimination of photoproducts". That sounds like substrate reduction to me.

So, is that saying CUV150, with results due in 2021, will perhaps be enough to allow patients with XP-C access the drug? Obviously it wouldn't be enough to allow population wide access, but maybe some of those 22 month goals PW has are enabled by this FDA guidance.

Interesting that XP was finally named after years of secrecy just a few months after this regulatory guidance. I wonder if the two were linked. Even if not, it's great to know the FDA is publishing recent guidance of relevance to CUV. JH, regarding your point about not knowing if a company has used this guidance for an approved drug, it actually says in the introduction "This document provides guidance to sponsors on the evidence necessary to demonstrate the effectiveness of investigational new drugs or new drug uses intended for slowly progressive, low-prevalence rare diseases that are associated with substrate deposition and are caused by single enzyme defects." So, that new drug uses bit deals in new indications for approved drugs, doesn't it?


Well-known member
So who’s offering the 1,600 shares at $150?

Generally retail holders can’t place orders that far out of the money, instos playing games again? There is also an awful lot of low vol trades (<20 shares) going through, again must be professionals as retail would be swamped with brokerage charges.

I wonder how closely ASIC is looking into this...
Last edited:


Well-known member

One more order added to the list:

[January 17] Sudtirol Health Authority - 66.525,00 AUD
[2020] Sudtirol Health Authority - 304.660,00 AUD
[March 18] Padua University Hospital - 871.880,00 AUD
[April 3] Padua Hospital - 661.480,00 AUD (this file will be deleted from the Smallpdf website on July 15, 2020, so I uploaded it here as an attachment to this post)
[April 24] Brescia Civil Hospital - 951.105,00 AUD
[April 30] University Hospital Giuliano Isontina - 70.300,00 AUD
[June 16] Maggiore Policlinico Hospital - 1.725.545,00 AUD
[October 9] ATS Sardegna - 46.620,00 AUD


Active member
A testimony to the slow grind forward of.clinuvel that is still ongoing. Every new implant changes the life of another patient. To see and understand this is a welcome compensation for over a decade of investment suffering trial and regulatory delays. I am totally.ready for the new strategic avenues announcement and hopefully this goes together with a significant growth in epp distribution for the last quarter. We should gain serious commercial traction into 2021 and expectations are very high for the next 48 months.


New member
@Blaunt “gender representation” at Clinuvel is probably the first thing to concern me (slightly) about management.
Get the best person for the job and the board END OF STORY.

Internet misunderstanding disclaimer: what concerns me is if Clinuvel is placating to social justice ideologies such as equal representation of sexes in the workforce and board (because equality) rather than employing the best person for the job. Further internet disclaimer: i could care less if it were 100% women, as long as they are the best candidate. View attachment 440
I wouldn't be too worried. On the contrary. If the gender ratio of the staff is closer to gender ratio of people if adequate qualifications, the chance of hiring the best people available increases in my opinion.
I work in social psychology and can tell you that talent is often overlooked because of unconscious biases.
This plays into the hand of companies who try to reduce these biases in hiring, because they can hire talent that might have been overlooked by others.
I seriously doubt that Clinuvel hired people because they are women.
I think it's more a case of hiring the best (available) people, noticing the company has a good gender ratio and then using that fact as a marketing talking point.

This is not the place for political discussions, so I want to limit myself to a more general statement on the gender / identity politics topic:
If you manage to cut through the exaggerations and straw-man-arguments on both sides of the debate, you will notice good arguments on both sides. Sadly SJWs and Anti-SJWs often seem unable to escape their own tribalism and prejudices and deny themselves the opportunity of a valuable debate.


Well-known member
If anyone has access to the Jefferies analysis by David Stanton, could they please post it in the analysts reports thread in Investor Research? I haven’t been able to access it yet but someone more intrepid may have done so already. It might be underwhelming but good to have a balance I guess🙄😁

CUV Quote (Yesterday's close)

Time: 12:39PM AEDT
Price: 21.95
Volume: 118491