rx, this statement was made by the CLDN CEO on Mar 30th,2015 before she announces the failure of MYDICAR and stock price collapsed on April 28th, 2015. Does it sound the familiar to ya ? GL
"In the last year, Celladon has made significant progress in our clinical programs and pre-commercial planning for MYDICAR, including preparations for commercial manufacturing and other long lead-time activities. Our CUPID2 trial is evaluating the use of MYDICAR to treat systolic heart failure, known as HFrEF, and we received Breakthrough Therapy designation for this program from the FDA in April of last year. The CUPID2 trial is proceeding according to plan and we look forward to un-blinding and announcing top-line data from this trial in late April 2015. Following last year's financing activities, we are well positioned to advance our pipeline and development initiatives in 2015," said Krisztina Zsebo, Ph.D., Chief Executive Officer of Celladon.
trader, did thegreyfog invite you to his tea leaves smoking party? that is NOT the tea leaves.. LOL
Sell in May and Go Away until Nov...don't believe any of these ASCO noise and irrelevant announcements coming up.. GL
Cathy, what is the rational for the CLDX to go higher from here ? CLDX market cap was $3Bil 2 days ago.
This company has no FDA approval, no drugs on the market, no revenue of any kind, no partnership with any major pharma company. One FDA fast track to treat limited patients for rare disease should not be valued at $3bil.
Pre-clinical positive results were not validated by any authority or the FDA. As the rare diseases harder and harder to treat, Late phase clinical trial failures should be expected, and CLDX is no exception.. GL
rx, you're stupid to make that kind of assumption..
same type of rhetoric were made by the CLDN's CEO prior to the clinical failure announcement. She said that she were excited and hardly wait to present the checkpoint data 1 month prior to the announcement, she also had PR 3 weeks before the checkpoint about the agreement with MFG for expansion ...
most investors took that as the sure thing for positive results, there were 4 major analysts raised PT to $70/shrs.. these were the coordinated efforts by WS to scam investors, and the last thing she said was: "We are surprised and very disappointed that Mydicar failed to meet the endpoints in the CUPID2 trial" and the CLDN stock price collapsed ..
this could happen to any R&D biotech company.. assume the worse and hope for the best .. GL
FDA doesn't grant approval based on someone observations.. FDA uses scientific methods to determine if the new therapy is statistically significant improvement comparing with placebo or existing drugs.. without data to prove the new drug was the main reason for longer survival, then all bets are off. Some placebo patients survive longer than the new drugs, so you can't rely on one Dr. observation to urge FDA approve the new drug. Besides, doctor's comments were biased because he was part of this study.. GL
when a biotech company reveals clinical failure to the public, there may be many more biotech companies have negative news that have yet to be revealed. By seeing one cockroach is usually evidence that there are many more that remain hidden.
In the recent high profile clinical failures like ACAD, CLDN, AERI, ATHX and others, this kind of negative results #$%$ investors to take a safer approach by taking money off of the table until company can prove their therapy works.. AERI and CLDN failures should be a good lesson for CLDX investors who are so confident that React final data, Varli and Rindo are sure thing... GL
looks like institutions are moving closer to the exit doors. Secondary investors are cashing out and moving on.. dump investors are holding on until the bad news released and then getting angry by listening to mindless pumpers on YMB... CLDX lost $650 Mil market caps for the past 2 days.. not a wake-up call ? GL
only third graders would make that kind of excuses .. grown up would not made up that #$%$ .. LMAO
CLDN up today, so pumpers can't use the mistake in identity reason of why CLDX down again after 16% drop... 2 consecutive dojis won't help either, any more pre-clinical results in the rat labs newsy ? more oppy to buy heh..... another 4% drop out of the gate.. and pumpers encourage investors to hang on to their rocks while sinking to the bottom... LMAO
never, looks like someone may have leaked clinical data to hedge funds.. over 5Mil shares sold today.. if insiders started unloading their shares.. place your sell market order and leave town..
similar trading pattern at CLDN before fail clinical trial was released.. GL
CLDN falls 81% after announced clinical results... another bioscam bites the dust.. there're more coming your way soon.... science, pipeline, robustness, positive publications, SI reduction, IO increases, positive pre-clinical results .. and many analyst upgrades.. same fraud, different stock... GL
what say you now dbegley ? did you bet your farm on big move upward after two consecutive dojis pattern ? do you want to buy an ocean front property in Arizona, it is only $1 per acrea, minimum $100K.. lowest price ever.. LMAO...
goforit, researchers focus on science while investors should focused on stock prices..
most of the time, researchers keep investors in the dark until the final announcement which may wipe out investors overnight like DNDN, ACAD, CLDN, ATHX, and many others..
Bio management, MMs, pumpers and hedgies serve their masters, not general public interests. Fake analysts upgrades/downgrades were signalling for their upcoming actions, never trust management who have no stake in the company. By not investing their own money in a company that indicates they have no commitment to the company's bottomlines.. investors should analyzed insider ownership number before investing a large sum of money..
CLDX drops 11% w/o news. bad news could take CLDX to cash value of $2.04...just sayin'... GL
pst, don't pull Clinton on me.. "It depends on what the meaning of the word 'is' is."
by definition: A binary event in the stock market and business world is an event that has two possible results, one typically being positive, the other negative -
if one event with 2 possible outcomes, then the probability of each outcome is 50%.. period....
rx, if not 50-50, then what is your number ? FDA doesn't grant P3 clinical trial unless data showed the potential either.. historically, P3 failure is 75% and many publications present the facts..you can google yourself..
Why Too Many Clinical Trials Fail -- And A Simple Solution That Could Increase Returns On Pharma R&D
The rate of late stage clinical trial failures is the single biggest determinant of returns on pharmaceutical R&D. The lion’s share of discovery and development costs come at the end of the process, and if those trials fail (whether for safety or lack of efficacy), all the capital invested up to that point is lost.
The entire early development process, therefore, is designed to de-risk those large and expensive pivotal trials that can lead to approval and sales. Smaller and cheaper clinical studies are meant to predict the outcome of the larger, more costly ones to come.
But the track record of the industry at achieving this ideal is patchy. Precisely what the success rate of late-stage trials is remains something of a debate, not least because such trials are a heterogeneous bunch. Many such trials are performed with a drug known to work safely in one indication, to support label expansion. Others are conducted with drugs that replicate the mechanism of action of another agent already proven in the chosen indication. Such trials, one might imagine have a disproportionately higher chance of success than the first late-stage trials of an agent with an untried mechanism of action.
Hence, while the oft-quoted figure for late-stage trial success is around 50%, the track record for novel, first-in-class agents is considerably lower: DrugBaron previously estimated it to be below 25%. Whatever the precise figure, the current failure rate is unexpectedly, and unwelcomely, high.
Aerie Pharmaceuticals Shares Fall 75% On Failed Phase 3 Trial...any clinical trial checkpoint is a binary event which is 50% chance could go either way.. don't get ahead of yourself believing that there's only positive outcome... GL.