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andymen
Posted on: Jun 9 2020, 12:56 PM


Group: Member
Posts: 54

https://www.bloombergquint.com/business/sho...-biotech-stocks

Article re biotech short selling, featuring CUV.
  Forum: By Share Code

andymen
Posted on: May 20 2020, 12:49 PM


Group: Member
Posts: 54

There's some info re DNA repair that was presented in the AGM presentation last year: https://newswire.iguana2.com/af5f4d73c1a54a...GM_Presentation


STRATEGY I ©
If one follows this concept of alpha-MSH analogues providing the ability to repair DNA damage, a primary question
to answer is: from where does this DNA damage arise?
With no coincidence, operating out of Australia, there is no other country globally lending credibility to its
scientific knowledge about UV-induced skin damage based on the incidence of non-melanoma (NMSC) and
melanoma skin cancers (MSC).
DNA damage originates from either UV induced radical oxygen species causing mutational changes to DNA in
keratinocytes and/or melanocytes, or it follows the decreased activity of DNA-reparative enzymes in genetic
disorders making patients much more prone to skin cancers.
Please bear with us and follow the concept, because we are nearing the centre and highlight of the strategic path:
DNA reparative mechanisms come in four, for today’s purpose we focus on one specific DNA reparative pathway,
the Nucleotide Excision Repair mechanism which is influenced and regulated by the melanocortin 1 receptor
(MC1R) and its downstream signalling. In other words, the MC1R is the socket for SCENESSE®, acting as a powerful
plug providing the electric current for the cell to repair DNA.
CLINUVEL knows from its own work, clinical trials and in vitro/vivo scientific data, but also from the emerging
science in melanocortins, that alpha-MSH – and therefore the more powerful version SCENESSE® - directly and
indirectly influences the DNA reparative pathway via Nucleotide Excision Repair through MC1R signalling and has
shown to exert a positive influence on photoproducts following UVR damage.
On the bottom of the slide are listed the three properties of alpha-MSH on DNA repair following UV damage:
1. ELIMINATES/DECREASES PHOTOPRODUCTS 6-4PP, CPD, T-T DIMERS
2. OPTIMISES MELANOCYTE OUTPUT→ MELANOGENESIS (PHYSICAL BARRIER)
3. OPTIMISES MC1R SIGNALLING
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andymen
Posted on: Mar 3 2020, 10:30 AM


Group: Member
Posts: 54

D'oh. Was looking for the detail in the text, and missed the headline blush.gif

Still, something happened to change their minds and propose two trials.
  Forum: By Share Code

andymen
Posted on: Mar 3 2020, 10:10 AM


Group: Member
Posts: 54

The initial announcement 3 weeks ago stated
"...to seek agreement on the design of a multicentre Phase IIb vitiligo clinical study (CUV104) and the data package necessary to support a supplemental New Drug Application (sNDA) filing for CLINUEL’s drug SCENESSE® (afamelanotide 16mg) in vitiligo."

So they are now proposing two trials CUV104 and CUV105. They also don't elaborate if they are Phase IIb or Phase III or one of each in this announcement. Hopefully they can run these trials concurrently. Looking forward to getting the study design details.
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andymen
Posted on: Mar 2 2020, 05:52 PM


Group: Member
Posts: 54

Some positives:

Dow futures currently up +314 as I write.

Shorts were down last Tuesday by 0.31%, so evidence that some shorts are starting to cover. Will be interesting to see where it's at by weeks end.

FDA meeting announcement re Vitiligo pending.
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andymen
Posted on: Mar 2 2020, 05:01 PM


Group: Member
Posts: 54

I know, definitely feeling it too.

Let's have a 'green day' tomorrow and remember that we're still breathing. In that spirit, enjoy smile.gif

https://www.youtube.com/watch?v=SUzsih7QJSY
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andymen
Posted on: Mar 2 2020, 03:00 PM


Group: Member
Posts: 54

Today is the 3-week anniversary of this announcement for a Type C meeting re Vitiligo.

Release Date: 10/02/20 10:01
Summary: Request for FDA Guidance Meeting SCENESSE in Vitiligo

In the announcement they said they expected a response within 3 weeks, so we should hear soon whether a meeting will be granted.

Perhaps FDA focus has been diverted due to the virus causing a delay?

An announcement regarding a meeting would be really welcomed about now!
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andymen
Posted on: Feb 6 2020, 04:29 PM


Group: Member
Posts: 54

Thanks for the explanation. I'm still getting my head around this.

If I'm understanding this correctly, you're saying that index funds use shorting as a means to re-balance or re-weight CUV in their fund, is this correct?

If so, when the price goes up, and they need to decrease their short position, how do they do this without buying more stock? Probably a silly question but I'm new to shorting!


I also note that the latest figure on shortman (31st Jan) showed outstanding shorts up 0.22% on a day that the sp increased nearly $1, the increase in shorts was therefore probably non-index fund related I would conclude. There are approx 4.4 mil outstanding short positions ATM, is there anyway of knowing how many are held by index funds?
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andymen
Posted on: Jan 21 2020, 07:39 AM


Group: Member
Posts: 54

I have been thinking lately, that perhaps the reason PW keeps a the $$ in the bank is to make CUV a more attractive T/O target.

Just speculation on my part.
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andymen
Posted on: Dec 30 2019, 11:09 AM


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Posts: 54

I really hope not. The day CUV announce an acquisition of AVH will be the day I sell out of CUV. DYOR.
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andymen
Posted on: Dec 20 2019, 11:52 PM


Group: Member
Posts: 54

First time I've heard of this one. Just been posted on FB.

https://www.clinuvel.com/photomedicine/scie...kFOS1o0DO91Bqco
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andymen
Posted on: Dec 13 2019, 03:40 PM


Group: Member
Posts: 54

And she says she takes 6 pills a day on the MT trial. How is that supposed to be more convenient?? laugh.gif
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andymen
Posted on: Nov 23 2019, 12:46 PM


Group: Member
Posts: 54

Found this while researching PNV.

Looks like Regal Funds Management is a shorter of CUV going by this report. (Thanks to Strangelogic at Hot Copper for the tip off)

Yesterday 10.53am
Pharmaceuticals
By Lucy Battersby and David Scutt
Speaking on pharmaceuticals, David Scutt is at the Sohn Hearts and Minds conference today. Fund managers deliver their best ideas to raise money for the charity's medical research.

So far this morning he has heard from Phil King of Regal Funds Management, who said the biggest bubble is Australia’s stock market are biotech companies.
Mr King specifically nominated Polynovo, Pro medicus, Avita, Nanosonics and Cliveul Pharma, or the ‘PPANCs’, David said.
Given Australia has limited experience in medical stocks, Mr King said this makes these type of stocks “prone to bubbles”. He put the explosive capital growth in these companies down to passive buying. As for the PPANC stock with greatest downside, Mr King was definitive: Polynovo.

Shares in Polynovo tanked soon after he made these comments, dropping nearly 5 per cent from $1.86 down to $1.76.

https://www.theage.com.au/business/markets/...122-p53d1m.html
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andymen
Posted on: Oct 31 2019, 08:43 AM


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Posts: 54

4C result in about 5 minutes time. I hoping for > $15 mil. Soon find out!
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andymen
Posted on: Oct 18 2019, 10:27 AM


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Posts: 54

Looks like the annual report will be release in the next few minutes.
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andymen
Posted on: Oct 10 2019, 07:19 PM


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Posts: 54

AUDIO TRANSCRIPT OF INVESTOR TELECONFERENCE

Now on website:

https://www.clinuvel.com/wp-content/uploads...2173-091019.mp3

Attached File(s)
Attached File  3A526056_CUV.pdf ( 123.83K ) Number of downloads: 91

 
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andymen
Posted on: Oct 10 2019, 09:45 AM


Group: Member
Posts: 54

https://www.livewiremarkets.com/wires/stres...michael-jackson

Not a bad little write up, looking at vitiligo potential.
  Forum: By Share Code

andymen
Posted on: Oct 10 2019, 09:30 AM


Group: Member
Posts: 54

https://hotcopper.com.au/threads/news-cuv-c...levels.5003369/

Confirmation of what was inferred on the teleconference.
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andymen
Posted on: Oct 9 2019, 10:39 PM


Group: Member
Posts: 54

https://www.shortman.com.au/stock?q=CUV

If I'm reading this correctly, looks like the shorts were squeezed today and they are halved to about 3% of shares.

Will be interesting to see tomorrow what they were as a % of today's volume.
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andymen
Posted on: Oct 9 2019, 01:42 PM


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Posts: 54

https://www.bloomberg.com/news/articles/201...a-drug-approval
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andymen
Posted on: Oct 9 2019, 11:06 AM


Group: Member
Posts: 54

Today's news hopefully puts a NASDAQ listing back on the near-term agenda. Would like to see that!
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andymen
Posted on: Oct 9 2019, 09:01 AM


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Posts: 54

I liked this bit:

“This event is transformational in that we are now accelerating our exchange with the FDA and European Medicines
Agency to expand the use of SCENESSE® in additional indications
, as the passing of time has unveiled that our
breakthrough technology deserves wider application in modern medicine. I am confident that our teams will
understand going forward that art and skills will be required to execute against due dates while containing the costs.
If the past had been arduous, the hard labour is just about to start,” Dr Wolgen said.
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andymen
Posted on: Oct 9 2019, 08:57 AM


Group: Member
Posts: 54

Slight delay for the open also announced:

09/10/2019 9:45AM ASX PRE_NR Ends: 10:06:20 (headline only)
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andymen
Posted on: Oct 9 2019, 06:57 AM


Group: Member
Posts: 54

Congrats to all!! This is fantastic.

I started buying in 2007, so 12 years for me. It's been a long road, but as has been mentioned earlier, I think this is just the beginning too.

Great to see they sorted through the CMC (manufacturing) issues, so congrats to the manufacturer too. It's not easy to set up GMP quality systems.

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andymen
Posted on: Sep 24 2019, 12:49 PM


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Posts: 54

CUV is top of the pops today for the ASX200


Attached File(s)
 
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andymen
Posted on: Jun 7 2019, 09:58 AM


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Posts: 54

Attached File  02112487.pdf ( 1.08MB ) Number of downloads: 162


Presentation Jefferies Healthcare
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andymen
Posted on: Jun 3 2019, 10:25 AM


Group: Member
Posts: 54

"We are sympathetic to the finite resources the US FDA currently has and will patiently wait for the communication on labelling and post-marketing commitments by 6 September,” Dr Wright concluded.

This bit is interesting. It's the only reason for the delay CUV have hinted at in the announcement.
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andymen
Posted on: Jun 3 2019, 10:14 AM


Group: Member
Posts: 54

duplicate
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andymen
Posted on: Jun 3 2019, 10:14 AM


Group: Member
Posts: 54

Attached File  02110931.pdf ( 115.77K ) Number of downloads: 760
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andymen
Posted on: May 28 2019, 04:28 PM


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Posts: 54

Remember when we used to get speeding tickets from the ASX? From memory we would get them if the price went up only a few %.

Not sure why we have not received one recently.
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andymen
Posted on: May 16 2019, 02:38 PM


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Posts: 54

Perhaps it's index funds getting in ahead of immanent ASX200 announcement?
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andymen
Posted on: May 14 2019, 10:15 AM


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Posts: 54

Yes, looks like Healthscope is currently in the asx100 and will be acquired soon by Brookfield, therefore freeing up a spot in both the asx100 and asx200 with CUV in pole position for the latter.

I'm hoping MS did due diligence on liquidity, as that appears the only hurdle now. We will find out for sure in approx 30 days.

I looked for the original link but could not find it, so re-posted what was on HC forum.
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andymen
Posted on: May 13 2019, 09:12 PM


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Posts: 54

Attached Image



Credit @WHY from Hot copper.
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andymen
Posted on: May 8 2019, 03:16 PM


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Posts: 54

I believe we'll have notification on ASX200 on 14th June. Inclusion followed a week later on the 21st, if successful. Here's hoping!
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andymen
Posted on: May 4 2019, 03:23 PM


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Posts: 54

Good to know the OpenLab s/w can handle user permissions and complies with the FDA 21 CFR Part 11. Thanks for the links.

Regarding "So it appears that the documentation provided by Clinuvel did not address setting up roles and permissions and needed to be updated because clearly the software can handle this type of thing.";

It's actually not CUV's responsibility to specify this. This is a requirement of manufacturing to GMP standard and ensures there is an audit trail of who did what and when. It should be Evonik's bread and butter, so to speak, as a GMP accredited facility. In fact, all of the audit findings are Evonik's responsibility to handle and remedy. I would think it's all sorted by now.
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andymen
Posted on: May 2 2019, 10:34 AM


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Posts: 54

I stand corrected. Apologies.
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andymen
Posted on: May 2 2019, 10:24 AM


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Posts: 54

He didn't say it's a 50% chance of approval, he said 50% of the risk:benefit equation is safety. Or to quote:

"The target for our teams over a decade has been on management of the safety profile of SCENESSE® since the drug’s “safety” forms the basis of the regulators’ scientific opinion on risk, 50% of the risk-benefit evaluation."

Safety of the drug is excellent, so your initial 75% probability is still conservative IMO. I would put it at ~90%.
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andymen
Posted on: Apr 17 2019, 10:56 PM


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Posts: 54

Just stumbled on this podcast from the 'Three Wise Monkeys'. It was released about a month ago. Discussion on CUV begins at about 25:30. Looks like one of the guys from Ethical Equities (www.ethicalequities.com.au) is one of the aforementioned Monkeys.

https://soundcloud.com/twmpodcast/17-appens...ticals-and-more
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andymen
Posted on: Apr 4 2019, 03:50 PM


Group: Member
Posts: 54

Not sure if this has been posted before but it provides a fairly good summary on dermatological candidates. Does not include XP though.

http://www.skintherapyletter.com/dermatology/afamelanotide/


Also, Afamelanotide came up last month in a review article on acne vulgaris:

https://www.ncbi.nlm.nih.gov/pubmed/30859308



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andymen
Posted on: Apr 4 2019, 12:18 PM


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Posts: 54

Goldman presentation released.


Attached File(s)
Attached File  02093313.pdf ( 1000.9K ) Number of downloads: 217

 
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andymen
Posted on: Mar 22 2019, 12:00 PM


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Posts: 54

Hi Johnny. If you are interested in skin medicine you may also like to research PolyNovo (PNV) https://polynovo.com.au/

It's a platform tech with many applications (and potential applications), huge patient benefit, already selling in to US hospitals. Some discussion here:https://hotcopper.com.au/asx/pnv/

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andymen
Posted on: Mar 20 2019, 01:04 PM


Group: Member
Posts: 54

If this was not a big accident then I think what you suggest is likely true.

The question now is, will they try it again?
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andymen
Posted on: Mar 20 2019, 11:27 AM


Group: Member
Posts: 54

Yes, automatic stop losses would definitely have been triggered, which just accelerated the decline. Didn't think of that. That should clear the decks.

Good to see a rebound occurring.
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andymen
Posted on: Mar 20 2019, 11:13 AM


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Posts: 54

It's a wild ride.

Someone must have wanted out in a hurry.
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andymen
Posted on: Feb 27 2019, 01:34 PM


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Posts: 54

Another update from Ethical Equities:

https://ethicalequities.com.au/blog/clinuve...f-year-results/

Matt has sold, Claude is holding on.
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andymen
Posted on: Feb 19 2019, 03:14 PM


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Posts: 54

Looks like it will be the highest closing price ever!
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andymen
Posted on: Feb 7 2019, 09:01 AM


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Posts: 54

New newsletter is out.
Attached File(s)
Attached File  02073405.pdf ( 272.31K ) Number of downloads: 220

 
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andymen
Posted on: Jan 16 2019, 08:35 AM


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Posts: 54

Another Simply Wall St article:

https://finance.yahoo.com/news/excited-clin...x-001246224.htm

Of minor interest only.
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andymen
Posted on: Sep 26 2018, 11:18 PM


Group: Member
Posts: 54

We've almost doubled SP in the space of a month! Now that I think about it, I'm surprise that an asx speeding ticket hasn't been issued. Would be interesting to see if we get one soon and what the response will be.

Verharven, could you please share where you obtain the CUV ranking. The only one I could find is this: https://www.marketindex.com.au/asx/cuv, placing us at 233.

However it looks like this includes all the ETFs and LICs, which I assume your reference doesn't.
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andymen
Posted on: Sep 12 2018, 01:54 PM


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Posts: 54

This from Hot Copper:

https://ethicalequities.com.au/2018/09/12/i...imited-asx-cuv/

Acknowledgement to Fire Bull.
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andymen
Posted on: Aug 8 2018, 04:24 PM


Group: Member
Posts: 54

I looked into this awhile back. This is what I found, hope it helps.
https://www.asx300list.com/

"The index consists of all S&P/ASX 200 companies plus 100 smaller-cap companies that have market capitalisations’ above ~$100 million (AUD)" and "The top 300 ASX stocks that meet minimum volume and investment benchmarks then become eligible for inclusion in the index."

Also from here: https://au.spindices.com/indices/equity/sp-asx-300
Stocks require a minimum Relative Liquidity of 30% for inclusion in the S&P/ASX 300. Should a stock’s Relative Liquidity drop to below half of this level at a semi-annual review it may be considered for removal.
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andymen
Posted on: Mar 9 2018, 11:37 AM


Group: Member
Posts: 54

According to this we are ranked at 380 in size:

https://www.marketindex.com.au/asx/cuv

So we're getting close!
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andymen
Posted on: Feb 20 2018, 10:53 AM


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Posts: 54

Up and running now.
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andymen
Posted on: Dec 28 2017, 12:44 PM


Group: Member
Posts: 54

Yes, I get that too. I just hit cancel and it goes on to open the page. It happens on both IE and Chrome.
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