How is ATOS going to market this test...the FDA says it's not reliable on a stand-alone basis. What clinic is going to use the test?
December 12, 2013
14:18 EDT ATOS FDA announces safety communication on mammography alternatives
In a notice posted on its website, the FDA is alerting the public, including women and health care providers, that a nipple aspirate test is not a replacement for mammography, other breast imaging tests, or breast biopsy, and should not be used by itself to screen for or diagnose breast cancer. The FDA says it is not aware of any valid scientific data to show that a nipple aspirate test by itself is an effective screening tool for any medical condition including the early detection of breast cancer or other breast disease. In its notice, the FDA notes that in February, the agency sent a warning letter to Atossa Genetics related to that company's marketing and promotion of a nipple aspirate test for uses that had not received FDA marketing clearance or approval. The FDA also noted that Atossa initiated a voluntary recall to remove its ForeCYTE Breast Health Test and the Mammary Aspiration Specimen Cytology Test from the market, with the FDA saying that it will continue to monitor, "the promotional activity of nipple aspirate test manufacturers, and keep the public and practitioners informed as new information becomes available."
From the press release:
"The OS analysis includes data on 67 events (patient deaths) out of a possible 124, whereas the PFS analysis includes data from 103 events. ImmunoCellular Therapeutics plans to continue following patients in this trial to collect more mature OS data. In the matured data from the open label, phase I trial, the Company observed a consistent benefit in both PFS and OS compared with historical controls, and on this basis thinks that it is possible that the primary OS benefit could be clarified as the phase II data mature."
So, if the Phase I trial showed long-term survival benefit improving as the data matured, why didn't IMUC take that into account in structuring the Phase II trial and the release of the data to coincide with mature data as well?
This trial seems flawed. We're talking a very difficult to treat cancer with short-term survival rate. Why would you release data after 67 / 124 people die. Naturally, if the Phase I data showed better survival data as the data matured, it would be self-destructive (as it proved last night) to release the data so soon. Maybe the majority of the remaining 50% of the population is responding to the therapy and will survive for 5 years per the Cedars-Sinai press release?
It's clear that IMUC's technology platform is not a cure given zero complete response rates, but stable disease is very valuable in such a hard to treat cancer. Too bad the design of the trial's statistical data release made it IMPOSSIBLE to show the true data on stable disease & overall survival.
Why doesn't IMUC review the biomarkers for the 50% who survived for 5-years so that the other 50% can get a different drug next time and the surviving 50% type patients are the ONLY ones who enter a Phase 3 to get I-107? We MUST start targeting / personalizing these medications better for Phase 3 trials...you'd get MUCH MUCH MUCH higher overall responses.
The FUTURE of medicine is drugs for cherry picked populations. Why doesn't IMUC research the genetic code for all 6 patients who had great responses, and then create a biomarker test for the common protein or enzyme that helps generate the positive response. THEN, all patients with gioblastoma having these traits can get 107 and have an amazing response.
This is how it will be done. Everyone is UNDERVALUING biotech firms, across the board...even after the big run this year. The entire gameplan will be changed. Big pharma and biotech will go back and review ALL failed trial results and try to identify those specific patients who actually responded. Then a targeted patient population will be given a targeted drug. There won't be trials involving hundreds of patience who's genetic make-up make success unattainable.
Buy EVERY biotech whose drug fails after they get crushed. EVERY ONE.
Yes, I just don't understand how you can have amazing progression free survival data announced two weeks ago and now get no statistical significance in overall survival rates?
The Cedars-Sinai data from 11/24 said giving ICT-107 creates long-term progression free, stable disease in 6/16 patients given the drug between May 2007 and Jan 2010. This data today is from 124 patients, a much larger pool, says the difference in progression-free survival is only two months.
So, a) Are these two different patient populations and two different trials? or b) The 11/24 data on 16 patients was a subset of the 124 patients in the larger trial? I presume IMUC's management were still blinded at 11/24 as to placebo effect and didn't just leave out from the 11/24 press release that the long-term progression free benefit was only a few months longer than placebo.
Help me understand this, because I think IMUC's management should never had produced the 11/24 press release without a comparison to placebo.
MASI has a strong position in patient monitoring in hospitals around the country
BEAT wants to dominate mobile monitoring healthcare
Seems like a no-brainer that ECTE will get purchased by one of these two firms.
Looking for $10 buyout.
Quarterly performance has been lower than expected and very disappointing. Most other cloud companies have been growing significantly, while ATTU is showing meager growth.
Now a secondary.
How about generating some revenue and cash flow instead!
Shareholder base has turned over a lot in the past week. Looking for stronger hands and move higher after the sell-off. Looking for Black Rock to add to their position.
Between options and restricted stock, Insiders own a lot of shares already.
What's needed is a better shareholder base and revenue to ramp.
WST, this is backdoor Secondary Offering...Lorem agreed to purchase shares from CYTX and CYTX is now registering those shares for sale to the public. Sorry, that's a Secondary by the transitive property.
P.S. $8 billion - as Chris Berman of ESPN would say, "C'mon Man". This is all smoke and mirrors to get a financing deal done, just like the Seaside deal was a bad deal.
So, you're exactly who I thought you were...a former investor who lost money and is trying to save the world from experiencing the same path you did. Well, forgive me father for I have sinned...I own stock in CLRX, and I am prepared to lose my entire investment, should that happen, as is the case with every stock in the stock market. And, not that I condone Mika and the Board's past mistakes. They clearly saw their semiconductor business become obsolete, and they make bad investments subsequently. But, that does not preclude them from ever getting it right. Just because you made a bad investment in Tegal, doesn't mean you always make bad investments. So, we all appreciate your narrative, for whatever reason you choose to remind us, but many men have failed once or twice before ultimately succeeding.
Depends on who a financing is with. 10-Q states there's enough cash to fund operations for 2014. So, there's clearly a ramp in the next 6 months, otherwise that's false disclosure, and Mika has stated in conference calls that revenue will begin to ramp in 2014. Regardless, I expect an offering at some point in the next 2 quarters. How this is done? Who the investment banker or placement agent is, or what terms CLRX will get, is currently unknown. It will depend on business developments in the next few months, the cash needs, the placement agent, and the future buyers. Having LIFE and DGX as customers and Everyday Health as a partner is meaningful, and given the explosive growth in genetic testing and the exponential number of developments taking place, providing the service / reporting / information that CLRX offers is of clear and growing need. I talk to physicians all the time, every day. Most don't have time to keep up with their medical literature, let alone the dynamic developments going on in genetic medicine. Cliff Notes to strategic decision making, and being able to link to source data, which is what CLRX offers, will only grow exponentially in demand. The market will be there, and clearly LIFE and DGX believe the service offering is compelling. At $12 million of value, that's attractive.
Why don't they sell off non-core assets, like this dental implant thing, and raise funds to expand the 3-D technology?
Don't like to invest in firm with so many disparate businesses that have no synergy.
EQ - what's your point on being on here if you're not short? Are you like trying to do a good deed or something to save people from investing? Seriously, what's your point, motivation, angle, etc.??????????????
A couple of things:
1) There's no way Life Technologies, Quest Diagnostics and Everyday Health don't partner with CLRX unless the product is compelling and provides strong value. That's a fact. Good news that Everyday Health has added the Melanoma Therapy Finder to its MedPage today, joining the Lung Therapy Finder, and continues to expand the relationship.
2) Management is being disciplined on cash burn, with certainly enough cash for the next 2-3 quarters. However, we should expect a secondary offering and welcome it. The reality is that CLRX will need more sales and marketing dollars to really drive home business development and usage of their products by both physicians (oncologists) and patients.
3) Fully diluted shares is 2.9 million, meaning the entire company is worth $12 million, assuming the cash is fully burnt right now.
4) The stock trades poorly...constantly spiking on news only to be shorted by daytraders due to lack of institutional support. The market capitalization and low float prevent institutions from owning the stock. As such, a secondary offering, placed with astute healthcare investors, would be an outstanding development...providing both cash and support for the stock...and potentially increased relationships in the healthcare community.
5) Do not expect much difference in this upcoming quarterly report. This is a development year for a development stage company. 2014 should begin the first signs of increasing revenue and significant operating leverage given the high gross margins (although that will be offset by higher SG&A costs)
Keep thinking of what the private market value would be for CLRX...if this was a Silicon Valley firm with venture capital dollars. It's valuation would be 3x higher right now.
Does every company disclose their deal terms? No, of course not...most don't. C'mon bro, give it up!
Non Exclusive enables CLRX to sign deals with other labs, otherwise, it would be a one-customer shop.
C'mon bro...give it up.
There won't be a revenue ramp until 2014 as that's when the LIFE deal starts kicking in to go along with their increased focus on developing a major testing business. The focus of the call tomorrow should be on how the LIFE deal is progressing, more info on the Quest deal, whether the rollout of the mobile Everyday Health app is ready, what the cash balance / usage / need is going forward, and how to attract better investors...which as you can tell, from all the news pops over the past year, since Tegal bought CollabRx, the result is a gap up in the stock price and massive shorting back down...every single time. So, the stock needs to be in much stronger hands so that the next pop keeps going. This business is worth well more than $12 million. Imagine CLRX was privately held, and they were coming public with Life Technologies and Quest Diagnostics as two of their customers and Everyday Health (similar to WebMD) as a partner. Valuation would be significantly higher. For the stock to be below where it was trading prior to the Quest news speaks to the weak shareholder base and the easy manipulation that can be done with a low float stock. So, this is a key focus going forward. I would welcome dilution to a group of healthcare focused funds, providing CLRX cash and an investor base that would support the stock.