April 24, 2014 7:09 pm
...Several large mines, including Century in Australia and Lisheen in Ireland are expected to shut in 2015.
“Over a three-year period commencing last year, approximately 1.5m tonnes of current zinc production will be closed due to mine depletion. This is a significant figure in a 13m tonne market,” said chief executive Don Lindsay on a call with analysts.
So many "me too" drugs that do the same thing and one will be made in US. Which drug should be designated preffered drug on US formularies? The US citizens will make sure the business you developed by charging US customers up to 10 times what other countries pay doesn't take this lying down.
Are investors selling hoping buy back after lockup expiration date?
Are there day traders playing with this stock still trying to make money on a daily bounce?
How low do you guys think this one can go? No volume makes me think we are seeing artificial prices reached by the boys trading between each other to see if they can cause a panic sell into a spiral?
GLTA, would love more at lower prices
What did the FDA have to see before giving BreakThrough status:
"This designation is intended to expedite the development and review of drugs for serious or life-threatening conditions and where (((preliminary clinical evidence suggests it provides a substantial improvement over existing therapies)))."
First drug trial where I've seen an SPA that set the primary point as Readmissions. Looks like the FDA looked at the updated 3 year results on the high dose patients and were convinced that Mydicar has the potential to save billions of $ in health care costs every year. And, approved (SPA) readmissions as a primary endpoint.
Found an interesting article:
A 10 Patient Case Report on the Impact of Plasmapheresis Upon Neutralizing Factors Against Adeno-associated Virus (AAV) Types 1, 2, 6, and 8
"we showed that after 1–5 PPs performed in a short period of time, NAF specific for AAV2, 1, 6, and 8 became undetectable for some patients when initial titers at the screening steps were ≤1:20. Furthermore, it was also possible to reduce the NAF titer to 1:5–1:2 but also for patients with low initial titers (≤1:20). Overcoming these residual NAF can be achieved by increasing vector dose, as previously described."
If you were aware of that information and you were talking to BIG Pharma about Mydicar would you sell the rights before a Plasmapheresis trial had the potential to add billion more to the sell price
It's a multibillion dollar drug if it improves on decreasig readmission rates if given at highest dose. Mydicar was able to reduce readmission rates for six months at the lower dose levels.
(Is this latest trial to makes sure you can't treat the additional 60% and get a $10B buyout price)
Piced up more at $12.50, thanks yall'
My hope for the lockup is that there are enough anxious sellers to create some cheap shares to be bought by long term buyers.
I'm comfortable with my holding but would love to pick up more shares at a cheaper price
First Cupid trial, many years ago:
"Only patients with undetectable neutralizing antibodies against AAV1 (titer
Was Mydicar the first "Breakthrough" that looked at a totally new type of therapy and say it should be given every opportunity to speedily move through the review process for the billions it could save our nations medical bill yearly? In addition to the fact that it has the potential to greatly improve the quality of the patients life.
FDA takes a close look at early data and grants "Breakthrough therapy" and agrees to an SPA that gives approval on basis of how soon a patient needs to be hospitalized post treatment.
expect dilution at $30 plus
Nothing should go wrong. Treated patients don't need to revisit the hospital after Mydicar treatment, unless the patient was too far gone at initiation.
Would love to see Celladon do another stock offer 5 millions shares at $30 partner off his product and take on the pulmonary indication. Would like a billion upfront. By the end of summer everyone running a trial site will have a very good idea why they have an arm of strong responders where there cardiac failure isn't spiraling to ever worse levels.
More leaks every week.
This one is going to save billions in health care dollars yearly.
Agree on possible buyout.
June 2, 2014
New CFO Paul Cleveland:
was Executive Vice President of Corporate Strategy and Chief Financial Officer of Aragon Pharmaceuticals, Inc. Aragon was sold to Johnson & Johnson in August 2013 for $1 billion.
Before the CUPID study....The analysis of multiple end points in early heart failure trials (versus a single primary end point such as ejection fraction [EF]) has also been suggested recently by the Food and Drug Administration in a cross-center guidance document pertaining to cellular therapy for cardiac disease.
After the FDA had a serious look at the date in the first Cupid Trial:
Celladon has obtained a Special Protocol Assessment (SPA), whereby the U.S. Food and Drug Administration (FDA) has agreed to use time-to-multiple heart failure-related hospitalizations in the presence of terminal events
And, granted "Breakthrough Therapy" for this SPA endpoint.
dawg, much appreciated. Been doing a lot of due diligence trying to poke some holes in what looks like a grossly undervalued company. Staying impressed, so far.
Looking at ages of each arm in the trial
Placebo - 61.0
Low Dose - 60.3
Mid Dose - 63.9
High Dose- 56.6
Would like to know how the high dose average skewed so much younger? Do some adjustments need to be made when comparing outcome of 56 yo patients to a 61 yo group? I'm sure there were some 60 year olds in the high dose arm and would love to know how they are faring.
This one will also save insurance companies on the rehospitalization cost, billions saved yearly. Should be easy to get Medicaid and Isurance to start paying. The Insurance Industry would also like to see even earlier intervention research to start ASAP?
Affordable and as an outpatient treatment. Could lead to heavy worldwide demand where an experienced partner like Roche may be willing to pay a HUGE upfront fee and royalty stream for distribution outside of US?
A huge improvement in patient outcome and affordable? Worldwide sales could become a serious focus and that would lead to partnering.
SCRIP Intelligence article
Celladon president and CEO Krisztina Zsebo:
KZ: Cost of goods is not going to be an issue. It's an important consideration and we have three strategic pharma investors – Pfizer, Novartis and Johnson & Johnson – and I can assure you that we endured the full extent of their diligence efforts on all aspects of our technology for many, many months at a time. I feel that we're on very solid footing with regards to the production and cost of goods.
investor relations Fredrik Wiklund:
We are working with Lonza, who are one of the absolute leaders in the industry of producing mass-scale biologics. We estimate that when we will be in full commercial mode and producing this, the cost of goods or the drug cost itself is really quite modest, probably $1,000 to $2,000 per dose per patient. When you put that in the context of what typical biological drugs cost on an annual basis, it's moderate.