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Oh, there you are.
What made you flip from your previous flop (again) ?
conversation with BioSpectrum Asia in Singapore, Mr Philippe Wolgen, managing director, Clinuvel Mr Philippe Wolgen, managing director, Clinuvel Singapore: Australia-based Clinuvel has developed SCENESSE, its proprietary first-in-class photo protective drug, for individuals who are at greatest risk from visible and ultraviolet (UV) light and as a repigmentation therapy. The company has been focusing on diseases where no existing preventative treatment exists. Clinuvel commenced a clinical program in 2006 which focused on the rare disease erythropoietic protoporphyria (EPP), a metabolic disorder which causes painful burning reactions under the skin after even brief exposure to sunlight. In 2015, the drug has been approved for marketing authorization under exceptional circumstances by the European Medicines Agency for EPP and Clinuvel is currently trialing SCENESSE in a range of light and UV related skin disorders (photodermatoses) and as a repigmentation therapy in vitiligo. In a conversation with BioSpectrum Asia in Singapore, Mr Philippe Wolgen, managing director, Clinuvel highlights the company's strategies to get access to new market and his keen interest in Singapore as the gateway. For how long has Clinuvel been present in Singapore? What are the major activities in the center? Clinuvel has been in Singapore for three years. We first started with clinical works in partnership with National Skin Center and now we are building our labs to do chemistry and more fundamental work in Singapore. The reason for enhancing our presence in Singapore is to have access to better people and central location that is easily reachable from Australia as well as Europe. The future is Asia, hence looking at the market forecast, this would be a strategic movement. How significant is Asia for Clinuvel? What are major challenges of entering into new market? Currently, the focus on Asia is pretty small but the market is bound to grow. Clinuvel is focusing on a skin condition, vitiligo, in which the skin loses its pigments. It is more prevalent in Asia than US and Europe. Many of the Indian patients we know are stigmatized because of the disease. India is an important market for us but we cannot enter directly into the region so we are taking a step-wise procedure. First we want to strengthen our base in Singapore and then enter India market. We are aware of all the important clinical institutes and associations in India. However, we do not have plans to do trials in India since the regulations for doing trial is difficult in that part of the geography. We want to take our data from US, Europe and Singapore clinical trials to India. Another major problem in India is patient adherence to trial compliances. Sometimes patients have to travel few miles to reach to the trial center and sometimes they just quit the trial half way. That doesn't contribute to our clinical research. -
See more at: http://www.biospectrumasia.com/biospectrum/opinion/223165/mid-sized-companies-able-achieve-pharma-companies-drug-development#sthash.xLYaxIeO.dpuf
Read more at: http://www.biospectrumasia.com/biospectrum/opinion/223165/mid-sized-companies-able-achieve-pharma-companies-drug-development
And then 30 days before the minutes are official. End of March we will most likely get some very good news.
Is that B ABSSSI or the whole platform ?
I'd say about 4-5 years to be realistic.
I'm speculating that chances of a breakthrough designation might be bigger if DF has more time to do data analysis on e.g. ovarian. Personally, I'm a little surprised that we haven't discussed breakthrough for K for quite some time.
Some time ago I remember the company talking about a possibility for a breakthrough application for K, which would indeed make sense.
The trial extension at DF could produce the needed data to make such an application realistic.
Progress. Recently posted on company website:
http://clinuvel.com/images/pdf/SCENESSE-afamelanotide16mgPIL.pdf
And please let me add: There is a huge need for a professional PR person instead of Leo who might have many qualities. Strategic communication isn't one of them.
Totally agree. It's immature.
Good suggestion. I don't have the expertise to do that, but I hope that LR and other poster would have time to write.
No, no & hopefully
I wonder how Leo sleeps at night these days. And I'm not sarcastic here. Seriously, it's not a moment of zen for a CEO with the problems stacking up like this. Is he rock steady ? Is he having nervous bowel movements ? As this stock reaches divorce territory (and worse), a CEO who 'cares' about his shareholders must feel a certain pressure. I hope he's up to the task. Those of you who met him in SF: How did he look ?
Buddy, I'm the one drinking here. You too ? This is buy, buy buy if you ever believed in this company('s pipeline).
Green close ???
Arh, must be the whiskey talking.
I feel like the bartender who thought he just won the powerball only to realize the number were from the previous draw.
I have never invested in a company and endured a paper loss a big as this one. That's my point. I made a mistake and that's my fault alone. Holding though.
My worst ever. Hopefully we will all look like geniuses for holding a few years down the road. Not amused right now, though.
... in the not so distant future.
They need to accept that Leo apparently has no credibility and since a new CEO is out of the question they need to hire a killer name as CFO, attract world class names to the BOD, let Dr. J speak more on behalf of the company for a while, hire a professional PR company and accept a lower than expected bid for one of the compounds from a potential partner.
At some point CTIX will implode if this continues.
This is the most frustrating investment I've ever made. Leo seems to have 0 credibility. At some point soon the company will have to acknowledge that and act accordingly.
Terrific. Thanks a lot. Will be interesting.
NR, if you have a chance I'd appreciate if you could ask management when they expect Kevetrin to reach the same level of awareness in the scientific, journalistic and public areas ? As many have pointed out, there are a number of p53 activating plays out there. Kevetrin seems like one of the most promising (to informed investors) yet there are no real mention in scientific articles or news papers. Does management think they have done enough to promote Kevetrin, are they planning on doing more and when do they believe Kevetrin will get broad recognition and media attention (if ever) ?
Thanks.
I think it's because the deadline for joining has passed. It seems this page is only for 'joining' and once the deadline is passed they remove the information in order only to have active cared where there is still a chance to join. I don't think you can join the class action against CTIX anymore hence the removal. I don't think it's because they are dropping the case. Unfortunately.
That's an arrogant reply to a legit question.
Glad I didn't buy more in anticipation of big, momentous news. History is repeating.
True. Much better
Both him and Menon really need new head shots. Menon looks like someone who's been arrested and Leo looks like a used cars salesman. Please ask them politely at the meeting to hire a professional photographer for an hour or two.
Please don't get your hopes up. Material news cannot be held back.
My instincts tell me to buy more before the meeting but my brain stops me. When have we ever as a conference or public event where expectations have been met ? And when have we ever had a conference or public event where the pps didn't tank afterwards ? This might be a first, but I'm reluctant to bet on that.
I don't think Leo will release "momentous" news at the meeting and I think the pps will go down the day after. Sadly enough.
Don't count on it. Watch @VXL. Total disaster after uplist.
I'm beginning to think that for the sake of humanity it would be better if CTIX were a private company.
And please shoot some photos and maybe some videos for us who can't attend. Maybe some Periscoping from the meeting ? Would be awesome.
Now I'm even more confused. Anyways, we all know someone who knows someone who thinks CTIX will go beyond $2. And it will.
Cheers.
I believe so. We all could. If you put your shares up for sale at e.g. double today's pps they are not available for shorting. But you'd need to remember to move your limit order up when the pps moves up in order to keep the shares. If really big investors did this the shares that would be available for shorting (borrowing) would be significantly lower. Please correct me if I'm wrong.
Frankly, it took so much time that I got lost in the rhetorics. But after re-reading it still seems that you label a ph1 as a failure if MTD is not reached, yet you won't call the drug a failure when, subsequently, it is approved after a ph2 and a ph3.
Ok. So Imbruvica is a failure. Thank you for making that clear.
I'd really appreciate an answer to this :
Kevetrin is by no means alone. It is very common that a MTD is not reached. One example is Imbruvica (ibrutinib).
Pharmacyclics was bought by AbbVie for $21bn and Imbruvica (approved for CLL) has projected peak sales of $7bn.
The primary endpoint was to establish MTD. Due to low toxicity they never did so yet the drug is highly efficient.
Please tell me if you also consider the ph1 for Imbruvica a failure?