FWIW, getting very comfortable going into the weekend (in case we don't get any news tomorrow).

Big block action last few days has been very good. Net inflow today (from big blocks) is close to $1 million with 60k, 112k and 102k buys during different times since morning. There were 3 sells (10k, 14k and 23k blocks) that I would dismiss as someone who doesn't want to wait.. Doubt they are fresh 'shorts' as no more shares are available to short.

All in all, CLSN holding pretty good at this level going into end of Jan with impending data release. Good luck to all longs.

Just to be LOUD and CLEAR , jan month release is just a guideline, Co is going out of their way in responding to shareholders for confirmation. They have every right to delay if they want to for whatever reason but looks like they won't

Lawsuits ? Lol....have u ever read the term 'boilerplate' ?

Weird block trades so far. A big block buy at higher level after a sell...someone is playing games.

Getting more confident that the news will be positive.

Got another confirmation today from JC.

Kris
Phase 3 data announcement still in Jan 2013
Jeff Church

Sent from my iPhone

It's all about the data at this point.

Insiders are forbidden to sell being close to release of results. For the shelf, management has clearly said no placement until the results are out. No worries here..

I will be watching for a tell tale signs today especially on # and size of big blocks (buy vs sells). 'People who know know CLSN (BDO)'..lol

Agree. I strongly suspect (again, it's my opinion only) that Hisun has a very good idea on the trial outcome from their local contacts. As much as CLSN, they have big stake too in terms of both manufacturing contract as well as selling the Tdox to vast number of HCC patients in China, Hongkong etc.

Hisun could have inked an agreement 4Q 2012 or even earlier but with no certainty on when the results will be announced or 380 will be evented, they could not possibly sign an open-ended contract with CLSN. The 60 day period does exactly opposite - being closer to data release window.

Finally I have seen others pointing out that $5 mill is a chump change for Hisun for taking the risk but I don't buy that argument. Apart from money, they as a premier pharma company in China would look real stupid if the results come out negative days after the deal was signed with a non-refundable deposit.

And to add, if trial ends up with higher % of patients who have larger than 3.5 cm where RFA is proven to be not that effective.

Also I should add that a range from 12 to 18 still will meet the trial expectation. A 50% margin..a comfortable thought indeed

If I may, I think LTG has a good point. He was referring to the management's take on RFA PFS. Albeit historical number, they must have a very good basis for reiterating the number '12' not once but multiple times and that too on CC.

They indeed would be very surpised to find it's 50% more. Not that I am holding them to their statement but they too must have beaten this to death before they repeatedly made that statement.

That's what I think as well. I am leaning towards the explanation that AVII77 put forward on IV board. A good re-read, IMHO..

Excellent post and your reference to how TDOX impacts distant mets nails it...

I can almost gurrantee you that we will see positive results next few days..

IC-107 being their flagship product and most promising (so far), I expect $4 to $5 short term. It will greatly help to validate their dendritic cell based immunotherapy. If DNDN is north of $6 with their Gen 1 platform, IMUC should deserve better.

Yep..Look at the big buy blocks went thru today..there is a 115k buy at 7.73..wow

If China NDA does not require any reference country approval, then I am curious why the Hisun terms (part 2) is conditional - upon Positive HEAT results ? I assume that means they will not sign unless the PFS diff is minimum 33%

to quote an astute poster Avii77 from IV message board

Thoughts on yesterdays news and top line data release

From the Nov CC

Michael H. Tardugno - President, Chief Executive Officer & Director

I don’t think at this point we’re in a position to really talk anymore about interactions with other companies. Although, they are happening and they are frequent and they certainly take some of our precious time and resource, but a priority for the company nonetheless. Our expectation is that post positive data will be entertaining multiple term sheets. Now, whether those terms sheets will address a regional license or larger, will really be the function of other company’s interest. Our sense is on positive data the company will realize the best terms for license. So we’re operating with some patience and expect that our patience will pay off.

And Sia's interpretation:

Licensing interest remains very high, but management basically reconfirmed that they won't sign any license deals until data is released in January, at which point, the company would be "entertaining multiple term sheets". Its been a while since management has promised a large second deal, but they "expect our [their] patience to pay off" when it's all said and done. I personally think a licensing deal will RAPIDLY follow announcement of top-line results with a major big pharma company seeking aggressive expansion in emerging markets.

My thoughts: if management thought they should wait for the data to get the “best terms” I would have to say there is a damn good chance they (and their new partner) now know the final data.

Taking it one step further the question is: if “they” know, why no announcement?

One theory of mine: if the trial is successful they would continue to follow the patients and repeat treat as randomized to collect confirmatory OS efficacy data. However, if the trial is wildly successful, there would be an ethical need to consult with the FDA to allow placebo cross-over. This is what happened with Nexavar in RCC where the p value on PFS was <0.000001. They met with the FDA a few days after the final analysis of the PFS endpoint and the FDA said ethics demand that they give the control group the opportunity to cross (recognizing that the confirmatory OS data would be diluted). Now wouldn’t that be nice? (BTW, if PFS is doubled in this trial, the p value would be in the neighborhood of the Nexavar results above.)

One other unrelated point: I wouldn’t be surprised if there is no winner to Dcups Yahoo contest. ASCO (and other conferences) strongly discourage the release of anything but qualitative data before scientific release. Management said (Nov CC):

Again, as you know, what we’re trying to do is protect the data in order for it to first undergo a peer review process and that will afford us to get publications in very high quality journals. Again, as you know, journals will not publish data if it’s already been publically released.


So for me I’ll be very jealous of releasing much data after that before it goes to a regulatory review and before it goes to a peer review. Again, if you look at other examples of great drugs that work in the area of liver cancers and other cancers you’ll see that that is usually the path that is followed.


So “top line” data may be something like: “we achieved stat sig on our primary endpoint” or “we more than double PFS in this population”. But quantitative data like HR, MST's, P-values? I think we may have to wait to get the exact numbers. (My entry into Dcups yahoo contest for the announcement of median PFS numbers would have had a date of June 1 2013)

Good point. Also if you read my earlier post, the agreement with Hisun specifically mandates for the HEAT trial to be positive which means only one thing:

33% or greater and we are off to the races for both US FDA and China sFDA.

When the data comes out positive, it will be indeed a HUGE jump on the PPS likely to be in $20's...as having bagged a very lucrative China deal, CLSN will literally explode.

I see SRPT 'act' coming our way

It all depends on IC-107 PIIb results due this Q. The stock will not look back if the saftey and efficacy on the interim look meets expectation.

Last year CNN Dr. Sanjay Gupta covered a nice clip on the brain cancer and specifically showcased few patients are who still alive after expremental IC-107 treatment.

Well said, here is my thesis that the results very likely to be positive.

1. Hisun signs a deal with Part 2 being back-end loaded heavily. Read the wording carefully:
Part 2:

Pending positive HEAT Phase III data, we anticipate Hisun to exercise its option and put in place the second part of this agreement with Celsion on the commercialization front, outline below.



2. The key is Pending positive HEAT Phase III data

3. I think Hisun has a very good idea on the outcome or atleast very confident as much as Celsion management is to put down $5 million and they want to lock in.

4. Finally why bother inking a deal with a non-refundable deposit if neither side feels confident closer to the data release.

5. The news would not be viewed as such if it were to be announced earlier to the unbinding; so timing is another key bullish factor.

Hisun's domestic sales network is fast..from their website. I predict strong sales and quick adoption of Tdox within China..

HISUN's sales network extends to around 100 major cities in Shangdong, Liaoning, Beijing, Zhejiang, Shanghai, Jiangsu, and 26 other provinces, autonomous regions and municipalities of China. The company' business involves the production and sales of more than 70 anti-tumor, anti-inflammatory, and cardiovascular drugs. We have a team of more than 400 professionals working to provide services to 2,383 hospitals, all ranked upper second-class or above.

Exactly. I really doubt Jeff Church wouldn't know of a possible delay at this stage. He has twice confirmed that the Jan guideline still stands.

FWIW, the net block trades were positive today totaling a value of $345k. A 50k and 29k buys went at 7.70 and 7.90 respectively during last 1 hr of trading.

Probably that's the case..still they could have stated their assumptions more clearly. Anyway, who cares..I won't anymore.

$20 on positive results minimum

Roth the sloth company is an idiot . They are trying to get fatcat clients cheap upon positive results. $10., give me a break

FWIW, response from Jeff Church..this morning to my request for confirmation on the timeline for HEAT results. Sounds bullish without disclosing any material news

The Company’s earlier guidance of January 2013 still holds. See the announcement that went out this morning regarding marketing deal with Hisun Pharmaceutical Co. pre-data.

Jeffrey W. Church
Senior VP, Corporate Strategy & Investor Relations
Celsion Corporation
997 Lenox Drive, Suite 100
Lawrenceville, NJ 08648
Phone: 609-896-9100
Direct: 609-482-2455

This deal is a great bullish sign, imho. Chinese companies do not easily sign such a deal if they are not confident. I wonder if hisun have an 'idea' on the HEAT outcome...lol

Lol thinking to get a better one with my CLSN profits

Oh yeah..lol.. I think 3 day weekend should be plenty to pull PR together. That was my reason. As to whether it's good or bad, my crystal ball is all cloudy

My guess is tomorrow to clarify. At this point keeping my fingers and toes crossed.

Lol..quite a few maybe in line to grab cheapo shares

Me too. Any pre-market news after long weekend is generally not good.

AF per his tweet is guessing results tomorrow. If not latest Wednesday.

My personal expectation was last Friday allowing partying over the long weekend ....lol

Let me take a stab..while I am not a short, I am pretty sure, most of the so-called 'shorts' are cats on the fence..waited too long to get in...now they want to get in cheap and probably few of them want to play the lotto as well. Majority of the true shorts have already covered per big blocks last week.

Their motivation is simple --> to get some cheap shares..

While on this topic, one naysayer I would like to see eat the crow is Adam F. He is on record to say the results will be negative per his F-A rule.

Like the fact that it's both safety and efficacy. INO will be off to races if the results come out positive. Any idea on when it will be ?

The way I envision is exactly how other biotechs come to my mind. Release a PR announcing top results (I very expect positive somewhere on the headline) and the time of the CC embedded on the PR. The CC likely to be around 11 AM for the analysts to digest and react to the news (also they can come prepared for Q&A). So likely timeline:

1. PR before 8 AM
2. CC at 11 AM.

For PDUFA, company has no control; so the stock gets halted etc.

Good find. Come EOY 2013, these clowns will look more stupid to see pps raise significantly. I wonder what was their investment thesis in the first place. If one doesn't have long term vision on a biotech, they are poor candidates to invest in the first place.

My simple thesis for going long on clsn is as follows;

1. Interim results gave some indication on how good TDOX arm is working to company insiders. May be a wink or a nod from the DMC..who knows but I am willing to bet, management got some clue.

2. That clue is sufficient for them not to raise additional capital and instead buy more shares. Knowing that a failure is not an option, this is more of a insider 'know how' than a gutsy move.

3. Management had plenty of opportunity to raise capital but they did not. One has to wonder why ?

4. Not a single share has been sold by the insiders last few years.

5. Recent CC's have been nothing but upbeat -- bordering on almost 'irrational exhuberance' (apology to Greenspan..lol).

6. Science is solid

Roth's price target game..

This is how I read Roth's recent ridiculous price target of $10. They are playing it both ways. If the results are less than stellar, they haven't put too much hope. On the other hand, if they are great, some traders and short term investors would sell around this mark or slightly higher. Roth and their fat clients would scoop as much as they can at these levels. I bet Roth will up the PT soon after to $20 range.

Roth is nothing but a wolf in disguise..

P.S: I am willing to go on limb that PPS will be north of $20 upon +ve results release only to make Roth & Sloth company stupid

Looking at the blocks that went buy, I bet there was lot of short covering prior to the news. I don't think any of those were big instituional buys as they can afford to wait until the results are out. If they did not load up at 2's why should they do now...the investment thesis has not changed since then.

The good news is shorts having coverd mostly, they are as panicked as longs are who lost their shares thru stop losses. First it's stupid to put a stop loss on a biotech waiting for a binary news. The stock will be halted for news and upon resume, it will either open several points lower or higher.

The odds of positive news is > 80% and probably higher with CFO reiterating recently both timeline and the brief comment on fundementals being strong. GLTA

This is very likely the scenario. Stronger the data, better the term sheet's terms in favor of Celsion. Still....may be Celsion is highly confident on its ability to run this huge P3 trial all by themselves..certainly the management actions says that (no additional funding prior to data release, insider buys etc).