No news is bad news.
After the European conference we had hope that some new distributor would be announced. Instead we eventually got a PR (at least the company is trying!) talking generally about the positive reception and about the interest in partnerships, etc. Had PLC something tangible to announce, they certainly would have, instead of the puffy, but empty, PR.
And, unfortunately, the same for the San Francisco conference.
Every day without news from those conferences was/is a bad day.
The positive aspect is that the company, by trying to keep things alive, has put out a couple of positively slanted PRs; the bad news is that they have had nothing specific to announce. And had they *anything* specific, no matter how minor, they certainly would have added it to those PRs.
THis is all very disappointing (as it must be for management). The previous upward momentum has been lost, and we've been without new developments for distribution, funding, partnerships for too long, given the initial positive reports from the trials and presentations.
Yes, sure, it's always possible that the company is in ongoing negotiations with some potential distributors or partners--I certainly hope so!--but the days without news are ominous.
<<<Last I saw, heart disease death rates were dropping. Many of the therapies produce miraculous-seeming results. It isn't as if nothing was working.>>>
In 1984 approximately 645,000 Americans died from cardiac related ailments. Still the number one leading cause of death among Americans, back then. In 2008 750,000 Americans died from those same heart illnesses.
In 1984 The U.S. had a total population of 235m, compared to 300m in 2008. Therefore, the population increase from 1984 to 2009 was 28%.
The mortality rate from heart disease increased by a margin of 16.5% in absolute numbers, from 1984 to 2008. Which shows that after 24 years, the medical community and scientists have only managed to decrease mortality in cardiac patients by a mere 9% if you account for the changes in population growth. The death rate from heart disease was .0275% of the population in 1984 compared to .0250% of the population today.
A 9% reduction in deaths after the introduction of Angioplasty, Stents, Statin Drugs, Heparin, Aspirin, Pacemakers, Cardioversion technology, Portable defibrilators, and continued application of CABG procedures, Smoking Cessation products like patches and such, new exercise regimens and supposedly better dieting habits.
TMR should not be included in this list because it is not in the frontline as a treatment option like the rest of these guys, due to its narrow FDA labeling.
This is like commissioning 10,000 ants to kill an elephant.
So there's no slam dunk here with the starters.
I'm just saying that any reasonably intelligent coach would now begin to substitute the starters who have not performed in the game (judging strictly from the score, excluding hype), with the bench player who has yet to touch the ball.
I think you overstate the case against existing therapy. Last I saw, heart disease death rates were dropping. Many of the therapies produce miraculous-seeming results. It isn't as if nothing was working.
Yeah, the TMR studies were under-powered for financial reasons, which is a kind of self-fulfilling portent of doom. But realistically, the patient-acquisition problem I referred to above means that patients will only be sent for TMR in non-acute settings after everyone's wrapped their heads around the problem. So the late-line-of-defense label isn't necessarily all that bad. The roughly 3 years of no marketing at all was shameful, though. The way it stands, TMR is rarely considered even for model candidates.
TMR shouldn't be a dead issue at all. Certainly not with Heart disease still the #1 killer of Americans 24 and older. Over 700,000 deaths each and every year is caused by various heart ailments. And this is with all the treatment options currently made available to patients.
Granted, TMR is not yet indicated as a first line defense for the treatment of coronary artery disease--and someone should investigate why it isn't made more broadly available, considering that all the other treament options, including angioplasty, angioplasty with stents, CABG (Coronary Atery Bypass Graft), statin usage, aspirin usage, heparin (blood thinner) therapy, exercise, diet modifications, smoking cessation, etc., are not working to reduce the number, or the upward momentum of people dying from this disease.
TMR was only approved as a a last line of defense for recalcitrant patients showing no positive response to the above mentioned therapies, or displaying unstable angina.
PLCSF accepted what they were given, and never pursued a broader label for the heart laser and TMR. Loss of market capitalization, cash on hand, as well as a major stock exchange listing, forced them to relinquish their goals and aspirations to acquire the respect and ubiquity TMR deserved.
So because of lingering deep seated resentment towards Dr. Rudko, by the medical community, for being audacious and brash enough to introduce a product that could potentially undercut the windfall pay days that CABG bestowed, they buried the company, the CEO and the therapy in a siberian-like detention center of medicine.
TMR would have been a cheaper and less invasive procedure compared to CABG, and that was just too much for the cardiologists and surgeons to bear.
And while this David vs. Goliath battle plays out, with David pretty much out for the count, Americans continue to die enmasse, from blockage and ischemia, not just in the artery and heart muscle, but in the bureaucracy of medicine as well.
I've never owned CGCP and I'm long PLCSF. I am a little bit of a "hater" because this company has never done anything but disappoint me and I can't think of anything positive to say. I used to personally know quite a few folks at PLC and have nothing personal against the company, but as an investment it's been a stinker. RG could be quite lucrative, but until proven wrong I will remain a "hater". Oddly enough I was taking exception to P42's comment about no news being bad news. I was defending PLC's lack of momentum. Isn't that positive?
We are all pretty much in the same situation here. Everyone is long this stock... just with different time horizons and price expectations. Let's try and get along. Don't make me pull the car over you two.
This back biting and bickering is not a constructive way of dealing with the frustration at the lack of news from PLC management. Honestly, they have ALWAYS SUCKED at communicating to us shareholders. How could you expect THAT to change when they are busier then ever -- and only as compentent at it as they have ever been? Ladies, these guys will never learn to put the seat down or change the roll for you. Boo-F'n-Hoo...
That is part of the "why" this stock sells at a 70% (plus) discount to intrinsic value -- our sub-mediocre management team. How could you expect any more then they are capable of?
Take a deep breath and relax. 5 years from now we'll still be complaining about the same things (am I the only married guy here?)... Only the stock price will be about $3 and I'll be @#$%en about how is should be $10.
What exactly were you expecting??? I sense your expectations and timeframes are rather unrealistic. A few weeks ago you were showering management with praise for a job for a job well done. The reality is the job is only 5% done. You seem to be missing the big picture in terms of what is required to successfuly bring a medical device to market and the time and expertise required. Much more will have to be done before you will see real momentum with this company. You also need to look at the current global economy and understand how it affects the medical device industry. Hospital capital budgets are still very constrained, captial investing is tight, etc.
Hill, you offer such a patronizing and inapt response: I wasn't addressing given stock price increments, in any given timeframe. I wasn't talking of the myriad aspects involved in bringing an fda-approved product to market in America: the trials, the approval, the marketing, etc.
I guess you have the right to conjure the contents of any post you want and then write a response to you contents that you imagined.
But, as I think I very clearly put forth, I was addressing the momentum that had built as a result of the Italian trial's positive initial results, their presentation and demonstation at the upcoming conferences, the announced addition of Asian distributors, , etc.; and the reasonable expectation that all of that would lead to one or more new distributors for some European countries in the successive weeks. And it was in relation to that prospect that I noted the absence of any news, and said that no news (no new distributors being announced) is bad news.
I didn't say that that was management's fault. Nor, do my observations contradict in any way my previous praise for the management's investigating CIN, conjuring and developing a product to deal with CIN, getting the European Mark for the product's marketing, getting involved with the Italian study, finding a few initial distributors, making the wise choice to attempt to utilize the European market and prove success and to leverage that into a means of finishing the American trials, instead of spending all the working capital and mortagaging the company's future by desperate financial measures in order to fund American trials before the company could sustain that pursuit.
My praise for all of that is the same, and is maintained in the same degree, as when I offered it several weeks ago.
But, Hill, my post didn't relate to the many obvious hurdles, trials, marketing, etc. that remain before Renal Guard reaches its full hoped-for success. And it didn't relate to any price expectations of the stock---today, or in a couple of months, or in a few years.
So you have no basis to say that my "expectations and timeframes are unrealistic," or that I'm "missing the picture...of what is required to successfully bring a medical device to market," etc., because I addressed none of those issues.
I was dealing in facts: initial partial postive trial results, announcement of Asian distributors, upcoming presentations and demonstrations at important conferences have not lead to a single announcement in regard to finding one new distributor. And, going forward, no news is bad news: it will mean that no European entity wants to distribute RG, or to partner with PLC, etc., at this stage.
And, it was not at all unreasonable to hope for a European distributor at this stage.
I'm sure that management as disappointed as us longs.
And as far as you are concerned, why not respond to a post that actually existed instead of one whose contents you make up in your own mind and then respond to.
Agreed, in general. We're back to looking for actual sales, quarter by quarter.
Just looking at my friends who have undergone CABG, the population of candidates for TMR ought to be substantial (partial loss of heart circulation long after grafting is almost the model indication for TMR). And probably more to the point, cath labs in Europe have been put on notice that there is an available treatment in Renal Guard that greatly reduces side effects of emergency procedures. So we can at least wait hopefully.
No, Jacosa, TMR has had over a decade to prove itself and, though utilized (and, more recently, with attempts and coordinated biologics), has only shown diminished, and diminishing, sales.
Indeed, PLC's 10k's for the last two years say outright the diminishing expectations for TMR income--for PLC, at least--in the future. (And, another company intensely devoted to TMR, and, unlike PLC, still devoted to developing newer, better aspects of TMR and TMR delivery, CGCP.pk, also cannot show profits).
Novadaq, PLC's TMR American utilizer, has shown no numbers to indicate good propects for future TMR expansion.
Yes, internationally, there is some TMR market, from which PLC can benefit directly, but it all seems marginal and limited.
So, bottom line, there is only one hope for PLC, and it is Renal Guard. ANd if it can't make it in Europe (which, fortunately, we can't say at this time--indeed there seemed hope coming off of the Italian trials, Europaen conference, etc), I don't see how it could/should make it in America.
So, I'd say the future hinges on finding new European distributors and partners for Renal Guard, and if we can't do that why would there be prospects in America worth spending clinical trial money on? On the other hand, should RG prove successful in Europe, clearly any money spent in America to get FDA approval would be well worth it.
So, no new news from Europe pursuant to the successful Italian trial, etc., and seems potentially grim to me.
Right now, I'm trying to grin and bear it. But, if it proves grim, as I suspect, I'm not sure I can bear it.
As I said, every day of no news, is bad news as far as the expansion and success of RG is concerned.