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So, no life until sometime next year?
This board about as dead as this stock?
Where is the life, people?!?
Yes it does, but in the wrong direction.
What happened to the support at 1.20?
I like upward movement as well as long as the PPS doesn't fall back or drop below previous levels the next day.
That's what I mean by "sustained."
Nothing truly tangible to report on the regulatory front (FDA, CFDA).
Until that happens you won't see any SUSTAINED upward movement of the stock price.
Best Possible Scenario?
For the identified subgroup cohort, OS reaches endpoint with statistical significance at the end of 2013.
The company is then sold to the highest bidder sometime in 2014.
This scenario could offer the best possible return to shareholders, IMHO.
The biggest fear, and the one which I believe is helping to keep the stock price down (in addition to abject market manipulation by hedge funds and MMs), is that another lengthy trial will be needed EVEN if statistical significance is achieved for the favorable subgroup cohorts.
Another lengthy trial means we're YEARS away from any meaningful revenue stream, and the dilution that would likely be necessary (despite what Hisun says).
That's the fear, and it's being priced into the stock. That fear won't be going away anytime soon, probably not until the end of the year at the earliest, IMHO.
MM's are given direction by the hedge funds, who control everything.
That's why retail investors leave the market for good, every year.
It's a rigged game and the house always wins.
Yes, we all hope for that, but what real and tangible catalyst will cause Celsion to sustain a rally?
Do you get the impression that they are"coasting," now that they have sufficient funds to operate for awhile?
I'm a bit concerned that no acquisitions have been made, despite all of the hype. How hard is this company working towards its goal?
Until wishy-washy words like "hope, may, potential," et al become less prevalent we won't see any sustained rallies in the share price.
An "understanding" with Hisun is not the same thing as a "definitive agreement."
We need more real and tangible results around partnerships and paths to regulatory approvals.
What was your impressions and takeaways?
Words like "hope" won't get it done.
How LONG does it take to evaluate data?
I need to listen to the CC replay before I move forward.
Three words I want to hear tomorrow:
Hisun, Hisun, Hisun.
Or Hisun, CFDA, and FDA (in that order).
Why not 0.73 as Alpha Exposure suggests?
Why 0.75?
They usually come out between 8:00 and 9:00 in the morning of the CC, but there is no guarantee of that.
Apprehensive. I hope they don't disappoint.
The fact that it didn't go up today is a bit of a concern.
The CFDA is far more important to Celsion than the FDA.
That is why Celsion has patents in all of the major Asian markets for its delivery mechanism.
Celsion can become a multi-billion-dollar market cap company with, or without the FDA. Period.
I agree.
He's probably already starting to write it, but I'm sure he's waiting to hear what is said at the CC before publishing it.
This is one of the most heavily manipulated stocks around.
Period.
Celsion has a "delivery platform," not a "drug."
Quoted from a different message board:
"Celsion has a "delivery platform," not a "drug." The "drug" delivered was doxorubicin, an already FDA approved drug for chemotherapy. What Celsion does is DELIVER already existing FDA approved drugs in a TARGETED fashion. They do this by encapsulating the approved drug in a liposome, that then "leaks" the drug on target when heat is applied. The benefit of this type of delivery is such that the drug is not delivered SYSTEMICALLY, thus causing much less side effects and much less damage to other parts of the body (in this case the heart).
What some fail to see is that the delivery platform worked VERY WELL. This was proven in the trial. There were NO SIDE EFFECTS. Do you have any idea what the side effects of doxorubicin are when administered systemically? It's catastrophic in some cases.
This "delivery platform" which is PATENTED, can be used to deliver just about ANYTHING in much lower dosages, with HIGHER concentrations to the targeted site. Celsion is working with other companies to encapsulate other products. It is of particular interest to companies whose drugs are going off patent, and could regain patent protection if encapsulated.
What went wrong in this particular trial is likely several things:
1) there was no protocol for the length of time heat was administered by RFA. This meant some got 20 minutes, some got 2 hours, and everything in between. The optimal length of time for Drug release has been determined to be 45 minutes. Had every one of the 700 patients received 45 minutes of RFA, the outcome would likely have been much better.
2) The FDA approved drug doxorubicin is probably not the best drug to target liver cancer with.
3) Distant metastases in liver cancer are a severe problem, and caused further problems in the trial, since the doxorubicin was highly targeted.
What does all that mean? It means Celsion has a very valuable proven drug delivery system, that must now be targeted to the right cancers with the right drugs.
Why, are you buying? :)
What I'd like to see from the earnings conference call:
We all know that will not be earnings for quite awhile; that's a given with most mid-stage biotechs. It would be nice to know the monthly cash-flow burn rate going forward, however.
Foremost, this conference call needs to be all about forward looking "guidance." Specifically, the roadmap how the delivery mechanism will be approved in the two major markets: Asia (China) and North America. As such, we need to hear the words "FDA" and "CFDA" during the conference call and what kinds of discussions Celsion has had with those two regulatory entities. (Note that SFDA has been changed to "China Food and Drug Administration.)
I'm hopeful that more HEAT study post-hoc data will be released, and that this data is ready to be submitted to the appropriate regulatory entities.
Without a path for regulatory approval, Celsion will likely remain stuck trading between 1.10 and 1.30. With negative news, it could gap lower towards its cash value of about 0.75/share. Good news of ANY kind will send the stock appropriately higher.
I remain bullish on the technology and the company, but we need to see some positive guidance from this conference call that will lend some staying power to any rally in the stock.
I have a feeling that we might touch 1.30 today.
Just a feeling. LOL.
Yep, earnings are irrelevant at this point.
It's news from Asia (Hisun) and any dialogue with the FDA which will drive the stock higher.
Until then, expect a trading range between 1.10 and 1.30.
Absolutely. I would not want to be on the sidelines from now leading up to the earnings release on the 8th.
We should hear more about earning (or cutting losses) on the 8th. I expect to hear updates in a lot of other areas.
ANY good news will drive this thing up 20-30% in a matter of a few days.
This will do nothing without PR.
Yes, I expected PR from the shareholders meeting.
But WHERE is it?
Nada.
I see a bid/ask of 1.29/1.30 using Scottrade.
Nice rally today. I just read QTR's SA article.
It's a nice spin, but I'm proceeding with caution. It's clear that certain individuals, hedge funds, and other entities (perhaps big pharmas vested in competing technologies) do not want CLSN to succeed, for whatever reason. And it worries me that it may start to trade like a ADR, especially if China is the only way to market the technology (e.g. LDA). Where does CLSN stand with regard to the FDA?
It is encouraging that Hisun is continuing its relationship with Celsion, but a MOU represents nothing new from what the companies had in their relationship six months ago.
As for catalysts? I'd hardly call the August 14th earnings call a "catalyst." There won't be any earnings. (But maybe a reduction in cash burn rate?) Unless profoundly new information is presented, it's doubtful that anything earth-shattering will be presented in D.C. in a couple of months? (One can only re-package the presentation of the same data so many different ways.) The DIGNITY Phase II Results "could" definitely be a catalyst, but "when" in 2014 will that study be completed and the results known? In short, I see no tangible "near-term" catalysts for the stock.
I write this without knowledge of what was presented at the shareholder's meeting today. We may see more information and press releases in the coming days which could be legitimate catalysts. I'm reasonably confident that the technology will work when implemented with the right parameters (e.g. RFA times). However, it may take more than my belief to get this approved for millions of suffering HCC patients.
Ultimately, the only true "catalysts" are approval by the relevant governmental agencies, thereby allowing this technology to realize the potential it might show for millions of HCC patients.
Let's all hope that CLSN gets to that stage.
When will we know what was stated at the shareholders meeting this morning?
Will there be another press release?
Surely there is more than just the news about Hisun relationship to discuss.
Those are "computer-generated" stories and usually have no relevance to unproven biotech companies.
The only thing that will make this thing move upward is good news from the shareholder meeting this morning.
It's nice to see more than 30,000 posts in a single day!
Oops, I meant 30 posts! :)
I believe it's 10:00 AM EST.
Can anyone else confirm or deny?
One more day!
And then the rocket leaves the pad!
A rather lackluster day with thin trading.
Everyone is waiting for Friday.
It can't get here fast enough!
It's not news, but rather a direct attempt at stock price manipulation.
I'd like to see the lawsuit turned around, and "Alpha Exposure" sued for libel and securities fraud.
This was done for humor only as I thought most people knew who Nikola (or Nikolas) Tesla was.
He discovered and is responsible for understanding many of the principles which are the underpinnings of RF ablation.
"And now you know the rest of the story..."
Nikolas Tesla sits on the Celsion BOD.
'Nuff said! :)
Yes.
I like the detailed title:
Phase 3 Randomized, Double-Blind, Dummy-Controlled Trial of Radiofrequency Ablation (RFA) + Lyso-Thermosensitive Liposomal Doxorubicin for Hepatocellular Carcinoma (HCC) Lesions 3-7 cm
NEWS Pending!
Shorts--watch and learn this morning.