Post by CUV101 of HotCopper:
I’ve had a couple of reads of the Chair’s newsletter. Wolgen and McLiesh have made an art form of the waffle. I am left wondering exactly what our Chairman was hoping to convey with this.
I think that the only thing that can be reliably concluded is that German distribution has not started yet. This is disappointing as Germany is likely to be the biggest market outside of the US. I understand the delay is due to privacy concerns with the disease registry. With peak Scenesse season being in the Summer, it is now probable that no (or very few sales) will be recorded in Germany until the next Northern Spring - 6 months. This will have no effect on the end game but will result in loss of momentum. Long term Clinuvel investors will not be surprised with the missed target that was previously announced to the market in June this year for a July start!
“We have now agreed to explore ways to expand the Group with the aim of being able to pay for the mandatory development of a paediatric formulation in EPP and SCENESSE® for vitiligo.” This statement seems to have opened up the question for ongoing funding for vitiligo. Although the term “Group” is used for the first time I really don’t think too much can be read into it. Around the time I first got interested in Clinuvel, ex director Jack Wood was in a YouTube clip speaking of a “platform” and various value adding strategies including deals with big pharma. These were expected to be made in 2010. It is worth a watch. It is just frustrating for all concerned that still 6 years later there has been no development in this area. As he alluded to new indications will become known during the development process. As an example no one would have considered successful dementia trials in an animal model with the same molecule that was originally developed to prevent skin cancers and is now approved to prevent symptoms in a disorder of haemoglobin synthesis! If any deal is done then using the BLS joint venture as an example it is likely to be unconventional and non value adding!
Our chairman also informed us that CUV9900 was not yet ready for human trials. This molecule was announced to the market as an exciting follow on compound over 6 years ago! The pace of development here can not be blamed on anyone else.
The pathetic telling off to shareholders from the Chairman suggests that he may be getting tired. If Clinuvel had honest and direct communication with shareholders then this would clearly not be necessary. As to suggest that this could slow down the regulatory process then this is just dishonest. Especially when some of the real delays to the regulatory process have never been disclosed, for example an inability to conduct clinical trials! Perhaps the Chairman should re read his previous communication to shareholders to see just how honest he and his team are in their dealings with us! Only 3 weeks to go to the FDA Scientific workshop on EPP, open to all and via webcast. According to Clinuvel “invitees only”, just another honest "mistake" in the best interests of Clinuvel!
Mr McLiesh also advises us that Clinuvel’s key professional investors have been increasing their stake in the company. I assume that this is Sean Parker who without buying more would now be below 5% due to dilution and would have provided notice of ceasing to be a substantial shareholder. I wonder. It will be revealed in the annual report soon enough.
Having staff work 24 hour shifts is not productive or something any manager should be proud of.
My final gripe is that another opportunity to present the agreed reimbursement price to the market is missed. The market is clearly not fully informed and this is not confidential information and is freely available.
The advantage is you can still buy this company for 300 million with an approved fantastic product. The disadvantage is the company is learning everything the hard way.
