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Not at all.
Japanese approval probably well before then.
Many catalysts in November, including the important P2 results.
Thanks for the information!
Be sure to fill us in with your impressions.
I hate to burst your bubble, but the current bid/ask is 5.96/6.15.
That said, it would be nice to see a little pop this morning.
Don't they have to disclose the terms?
What does this mean to the stock price today?
It's a casino.
And the house always wins.
I'm out as of this morning.
There are no short-term catalysts to drive the stock higher until later in the year or early next year.
Longer-term, things look promising. I will revisit CLSN at some point.
GLTA!
Finally!
Some good news?
Final HEAT Results
Maybe we'll see a little bounce today?
Closure.
I'm looking forward to read the final published results of the HEAT study which were presented at the conference this weekend. I hope they are released on Monday.
My, what could have been. If they had only included RF ablation time as an independent variable in the HEAT study many of us would have bought new cars, gone on expensive vacations, or whatever. It would have provided the needed statistical significance to the sub-groups which apparently DO show a lot of potential for the platform.
Now we're left to think of what might have been and await the follow-up of a new HEAT study to begin in 2014.
Depending what PR comes out early this week will drive me either to hold or to move on to greener grass. I'm thinking it will probably be the latter.
GLTA.
The calm before the storm?
Either we drop towards $1 next week or spike upwards towards $1.50.
Which will it be?
They do have a lot of potential.
There is no question about that. It's just that now the time horizon for any big gains have been pushed out 2-3 years with Mike's presentation yesterday.
Good luck with that.
You've totally convinced me with your unflappable logic. Carry on.
Yes, but what reason would they have to do so?
The technology won't be approved by the FDA for at least a couple of years now. How is that going to affect the stock price in the near-term? It surely can't help, right? I suppose we all can dream, but that won't affect reality.
What specifically will the "bulls" do to have an impact on FDA approval?
On what basis do you make that assertion?
What upcoming short-term "catalysts" does the stock have to drive it higher and sustain it higher?
I can't understand your English; can you repeat what you mean and why?
Quoted from another message board:
"What a kick in the coin purse. MT pretty much killed any hope for the Sept 14th presentation and all hopes that CLSN would have the data to go to the FDA or SFDA for that matter. Announcing another trial starting next year puts CLSN on the shelf for at least 3yrs. The dream is over but is not dead. I just wish I could take a 3yr nap and wake up to a blockbuster stock. With today's presentation we will see sub $1. I hate to admit it but CLSN is no closer than if they never ran a Heat study except they discovered that dwell time improves Thermodox and abalation vs abalation alone. How did they miss that in the first protocol for phase 3. It seems the Dignity trial was a smokescreen to soften the blow for announcing new Heat trial with longer durations. Very sad day for longs like myself that thought CLSN had some meat on the bone for chances of using sub group for approval in China. No mention of HINSUN agreement, nothing positive, we are dead in the water for years. If possible please convince me otherwise.... Not sure how u could."
It's tough to refute the cold facts. Can anyone?
I would not call them random bashings.
They are all carefully premeditated attacks designed to make money for the hedge funds they work for.
A new HEAT study is necessary.
This is according to the latest disclosure from the company this morning. This is something that many of us thought would be needed.
The new HEAT study trial enrollment to begin during the first half of 2014, dependent on approval by the FDA. So, no FDA approval is possible from the initial HEAT results.
The attendance at the Investors conference today is likely to line-up more money which will be required for the second HEAT trial. This means more dilution down the road.
Disappointing, to say the least.
I'll take it, but that's a pretty LONG march.
Frankly, if we stabilize at any level above 1.50 I'd be happy.
This "should" provide a little "pop" this morning.
It would be nice to see us close above 1.20 today.
Lowest volume of the year so far?
At least the price is holding up.
Has everyone left this board? :(
Yahoo "pulled" the "3 Stocks Going to Zero" article shortly after I commented about it:
"Interesting. Why pick these particular companies from the list of 10,000 that you cite?
I don't know about the other two companies, but in the case of Celsion you are only telling a tiny part of the story, without any mention of their relationship with Hisun, or the VERY POSITIVE post-hoc trial subgroup results, which will be officially released in September at the most prestigious cancer conference in the world.
The P3 trial was poorly conceived by the FDA and Celsion. RF ablation times were not a control (independent) variable, and it needed to be. RFA also needed to be administered closer to an hour after infusion rather than the 15-45 minute window for this trial. There still is a LOT of potential for this delivery mechanism and framework.
Also, I believe your cash-burn rates are inflated by up to 50%. (They have enough cash to last 3-4 years at current burn rates.) And even so, the company has never had a problem raising funds.
So, the prospect for Celsion stock going to zero is just about zero."
Agreed. This thing acts so predictably.
I was intrigued by the delivery platform. I still am.
I'm very disappointed the way the P3 trial was conducted, however.
Why did you buy the stock?
I'm not sure if the stock is undervalued at this point.
The only thing propping up the stock price at the moment is "hope." Hope that something "magical" will happen in the next few months, based on existing P3 trial data. Well folks, that data has already been sliced and diced. There is nothing else to learn from it.
A new (confirmatory) trial will be needed (at least by the FDA), and the CEO mentioned that during the last conference call.
As for Hisun and the CFDA, that's the only real positive wildcard left out there. And it's a longshot at best whether TDOX can be commercialized based on a failed P3 trial in China.
The ONLY short-term hope for investors is if the subgroup cohort showing the best results actually came from Chinese patient. Remember, there were only (15) U.S. patients in the entire trial!
I'm actually currently LONG, but underwater in two accounts with CLSN. :(
I'm not "bashing" or "cheerleading," just calling it as I see it. As you can see, the pre-market euphoria over the PR this morning has already subsided.
My opinion is just one of thousands. Everyone needs to do their own due diligence.
GLTA.
Is there REALLY anything "NEW" that isn't already known? I doubt it.
We're getting an nice little pop this morning, but it's not sustainable on this type of press release.
We're seeing a nice pop this morning on a restatement of the upcoming conference presentation in September.
The pop will likely last a few days, and then another gradual decline will set in until the actual presentation occurs.
Here are two very telling articles:
Part I
Part II
("Biotech Sage" is a very educated (PhD) biotech hedge fund investor.)
I read through both articles and I also completely read through over 200 comments (his, and other posters). He brings up a LOT of very good points, which were later borne out when he accurately predicted the P3 failure.
There are two major takeaways which are VERY telling to me:
1. Only (9) patients had HCC and only (1) patient in the original 24-patient P1 trial had a non-resectable HCC tumor greater than 3cm in size. A sample size of (1) as the basis for a fast-tracked clinical trial of 700 patients with tumor sizes between 3cm and 7cm? That seems preposterous, but maybe the FDA was looking at just the pre-clinical animal studies? To repeat, a P1 sample size of (1) for the tumor size range (3cm - 7cm) enrollment in the P3 trial? The P3 trial seemed destined to fail based on the incredibly small P1 sample size of (1) alone.
2. The data cited from Celsion's own presentations seemed to indicate that most of the TDOX wouldn't even have accumulated in the liver until at least one hour had passed, yet RFA was applied beginning 15 minutes after the original infusion? Now why did they make that apparent mistake by apparently starting the RFA too soon!?
The subsequent post-hoc data seems to corroborate the fact that maximum benefit did not occur until RFA was applied for at least 45 minutes. (And I suspect that even more benefit would be found if even longer RFA times are used, as more of the TDOX will have had time to accumulate in the liver.) If Celsion had looked at their own data more closely, they'd have known that in advance and would not have blown the P3 trial by starting the RFA too soon and for not applying it for a long enough duration. Sheesh.
Perhaps they learned as the trial unfolded that they needed the longer RFA ablation times, and that is what led to the extended enrollment periods?
Whether the FDA and/or CFDA will take a look at the possible later subgroup patient enrollment cohorts with seriousness (e.g. statistical significance) is the BILLION dollar question. It's questionable, at best. Unfortunately, I believe there is a high probability that the FDA will want a new trial, and that no regulatory approval will come from HEAT.
But there is always "hope."
Anemic volume?
Maybe everyone HAS given up? :(
Thanks. I wish I had more information to share.
I also wish that CLSN was moving more quickly, but we can't force the overall survival (OS) statistics out, as many people in the trial are still living!
That's why progression-free survival (PFS) is used more often to gauge the success of a trial. It doesn't take nearly as long to get results, and they are more focused on the underlying pathology.
I'm almost certain that Celsion will need another lengthy trial for Thermodox approval here in the U.S. market. And it's unclear whether they will get approval in China without one.
I am just so "upset" that the FDA screwed up the design of the P3 trial. WTH were they thinking!?! They have cost people's lives and investors hard-earned money by their misstep.
Science is process and a journey.
In biotech, the destination is either a better standard of care or an outright cure for a given disease.
Unfortunately for liver cancer patients, the Celsion P3 trial was poorly designed by the FDA. It made no effort to use RF ablation time as one of the control (independent) variables.
IF a more focused follow-up trial using RFA as one of the control variables confirms the LARGE (42%) sub-group data from P3, then I'd say that writing off Celsion is abjectly premature.
I expect that we'll know what the FDA has in store for Celsion by the end of the year. Hisun and the CFDA are the "wild card," however, as over half of the world's HCC patients live and die in China. They are likely to move faster than the FDA, as the largest P3 cohorts came from Asia and China.
I suppose the key is time:
How quickly does the stock go up after insider buying?
1 day? 1 week? 1 month? 1 quarter? 1 year?
Just curious.
Insider buying means nothing?
As per SEC rules they are not allowed to make purchases prior to known material events or disclosures.
This further confirms that there is NOTHING new on the horizon!
Where do you see that? I don't see it at Level II.
More insider buying this morning.
But only 10,000 shares. :(
Notwithstanding some huge news from Hisun (doubtful) there are simply no short-term catalysts to drive the stock higher for the remainder of this calendar year.
What happened to the P3a animal studies?
What happened to talks with the FDA?
What happened to talks with the CFDA?
What happened to the "10 companies being reviewed for acquisition?"
I suppose the only thing which might "happen" is reaching the endpoint for overall survival (OS). But that might not be until sometime next year, too.