It looks like a typo to me, that was the same percentage from the P II A trial
About CUPID 2b Clinical Trial
The Phase 2b study “Calcium Up-Regulation by Percutaneous Administration of Gene Therapy in Cardiac Disease” (CUPID Phase 2b Trial) is a multinational, multicenter, double-blind, placebo-controlled, randomized study of an intracoronary injection of MYDICAR® versus placebo added to an optimal Heart Failure regimen. The Phase 2b study of MYDICAR® reveals sustained improvement at one year in cardiac function criterion and quality of life, seeing an 88 percent risk reduction of major cardiovascular events including death,need for left ventricular assist device (LVAD) or heart transplant.
I bought 500 shares today at 16.53 - will buy another 500 after seeing what direction and the extent of that direction next week. Announcement could be as soon as Monday ( Hopefully and Pfizer or J and J buyout )
He is not short - he is getting paid 25 cents for every post he makes on behalf of some hedge fund. Ignore him - he has no information other than whats also available to you.
Hey, short interest ran up when CLDN went to 25+ for no apparent reason except for maybe irrational exuberance - if you could give " up to the moment " short interest, I would be willing to bet that this volume is because retail and weak hand / quick buck fund shorts are clamoring to unload - they have already made a huge buck. Potential buyers of this company are getting shares cheap. Again - the only downside I see is that the FDA requires a full blown P III study and this just gives potential buyers of CLDN time to get up to speed. PFE is coming folks
I think a bit of a nibble is appropriate at these levels - will probably average in 1000 shares - either direction
After a little bit of DD, you should notice the CFOs credentials, he was hired in 2014 after the CUPID1 trial. Pfizer wants to be a player in this space as well as a couple of other big pharmas, they already have big stakes and they can buy more during this downturn on the cheap, worst thing that can happen is that Mydicar gets forced into a full blown P III trial - all pharma is getting killed today but the volume on CLDN is telling. Everyone shorted this stock after the runup to +25, and rightly so - but I am betting they are selling their shorts as fast as they can right now - don't know whats going to happen first, a buyout or P II B data release, If I am Pfizer - I am at the table right now.
3 positive biopsies does not a FDA approval make. Again - I honestly feel that the FDA will require more data, Realise that these biopsies are very evasive procedures - you need to take tissue from the heart. Who in their right mind ( except the 3 you mentioned ) would volunteer for such a procedure. This is why I strongly feel that the best CLDN can do for shareholders is to sell, probably to Pfizer that has a gene therapy division, Pfizer has deep enough pockets to monetarily compensate patients for this procedure. Also - how many people were in this test group, I think there were 24 - 6 x low dose, 6 x med dose,, 6 x high dose and 6 x placebo. , a very small sample size.
A biopsy during the P II B trial would be more accurate, in fact many biopsies should be necessary before FDA approval - again, this is a new breed therapy, the FDA isn't just going to cut it loose on to the marketplace. AND - heart doctors are not going to clamor to use this drug even with FDA approval immediately after P II, way too much liability. I really think the FDA will request more detailed and conclusive evidence while they educate the medical establishment on the virtues of gene therapy. BTW, biopsies were done during P II A as well but too few to make a conclusive decision on efficacy.
I can tell that you are following the herd and not researching your investments.
CLDN has received " Breakthrough Therapy " designation from the FDA. This means that the FDA could approve this drug immediately following PII . It is the first time that the FDA has done this for a gene therapy drug and I would assume that they want to get it right, thats why I am not betting the farm here. I would guess that the FFDA may require additional data w/o a full blown P III.
Though CLDN has signed a manufacturing agreement with a firm back in December of last year in anticipation of going to market. Over zealousness ? I don't know. The one thing I do know - this is a whole new breed of therapy, exciting as it may be, medical institutions are leery of any new technologies for liability reasons and insurance companies more so. Think of the 1st heart transplant, there were not an additional 500 performed the following month after the 1st one. I may also mention that to make certain that this drug is performing as CLDN has indicated - a biopsy of heart tissue needs to be taken from a live patient, a very evasive procedure that I am not certain has been done to date. Lots of hurdles here though an FDA thumbs up with additional testing prior to a full approval for this drug will have Pfizer and Novartis knocking on their door ( both own approx. 5% of CLDN, purchased recently ). Another sign that CLDN may be on to something is that they received NASDAQ approval to award options to 3 new employees - these options are in the mid 20 range. If this was done at the employees request, that is a very favorable sign though I have noticed the planned sales of the CEO and other directors of options and it looks like this is how they are being paid. It is a catch a falling knife scenario - this company WILL be bought out, when is the question. I am betting on the FDA asking for more data, based on positive P II data, at the beginning thru mid May we could see an offer.
Operative word _ POTENTIAL
I for one am not quitting my day job while betting the farm on this drug - mainstream healthcare providers need to be convinced
I understand your comment though gene therapy will go the way that mechanical ( pacemakers ) therapies went, a long haul for patients expecting to have their carrier pay for treatment - unless there is a huge push by a REPUTABLE big pharma that has credibility this could take months to get thru administration reviews at insurance companies. Note that just because the FDA approves it, it doesn't mean insurance carriers a required to pay for it. Pfiizer and Novartis each have a big chunks of CLDN and I feel the best outcome would be for CLDN to sell to one of these companies, Believe me, this could be a blockbuster but I am always tentative and skeptical when a small, one shot company expects to bring a bombshell to market. Note also that the CEO once worked for a venture capitol firm - it would be interesting to know if Pfizer and/or Novartis have deals in place with this manufacturing firm CLDN signed with back in December. As for doing my DD on CLDN - I have put over 50 hours in over the last week getting a handle on this company, it screams buy - but then why the drop from 27 ? I am just scared there is a bit of irrational exuberance surrounding this stock. I will be in though should this go to 17 - remember how long to took to have heart transplants become common place ?
1: Solvaldi went thru P 3 trials with an 94% efficacy rating
2: Solvaldi is a cure, not a treatment
3: A behemoth biotech rammed it through
4: The amount of people suffering from Hep C is over 7 million
5: Biotech drugs are universally accepted in the healthcare industry
I just had a conversation with my sister, she runs a heart unit at fairly large hospital in suburban Chicago.
She tells me that regardless of the outcome of the PII study, insurance companies are not going to pay for this treatment - there is a huge hurdle to jump before gene therapy is common place and that a wonder drug company like CLDN has a very remote chance of getting this to market - even a Pfizer would need to jump thru hoops for at least a year to even get this treatment to the insurance review boards and fiscally it would need to make sense to the insurance industry. I wish it weren't so, sad commentary on our health insurance industry
I agree with heb2th9s - these people who sold are being paid with options and they are planned sales. Look up each person and note the days they exercised their options, it is fairly obvious. Pfizer and Novartis have their feet in the door of CLDN with large ownership stakes and I know that Pfizer does have an ongoing concern in gene therapy. I am waiting for sub 17.70 to pull the trigger - not much downside from there if the FDA forces CLDN into Phase III testing but it would be dead money for awhile even after a successful P II approval under BDN because this would be a sea change for the medical establishment and these people are not susceptable to change.
No way there is a potential of 18 billion in annual revenue, at least for GILD. After the Solvaldi/Harvoni price war GILD would never charge retail again and the CLDN drug is not a cure but rather a treatment. I agree there is huge potential for this drug but if you do your DD, Pfizer and Novartis ( both have approximate 5% stakes in the company ) have already got their foot in the door. I am seriously looking into buying CLDN by weeks end but I would like to see it sub 17.70 before pulling the trigger and each day you wait to buy could mean losing out on huge profits. If their large group efficacy can match the small group efficacy in earlier Phase II testing this drug could go to market by May though CLDN does not have a salesforce. They inked an agreement for manufacturing facilities a few weeks ago so I think they are fairly confident - Pfizer has a gene therapy division and I would think that they would be the first to make an offer. Roll out would be slow - gene therapy is a sea changing event and trying to get the medical establishment to change their ways would require a big pharma player to intercede on CLDNs behalf.
Go to the NASDAQ website - yahbo63 is simply incorrect - as of 3/13/2015 short interest has basically stayed the same for the last 3 months ( 52000 - 56000 )
Data isn't out for the EOQ1 2015 - that is EOQ4 2014 ownership breakouts. Lot of big players upped their stakes during Q4 2014 ( incl. CITI, 57% ) - with the fundamentals of GILD and the downward pressure during Q1 2015, I would have to imagine that these players added - what else that will drive up institutional ownership is that GILD in a likelihood was buying back stock from the leftover 3 B from a previous buyback plan - ( if the total shares outstanding is 100, institutions own 50 - then 5 are taken off the market making outstanding shares 95, institutional percentage goes higher by default )