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Would a DMC ever stop a Ph II trial for superior efficacy? It would seem this could hurt a company more than help as it limits the data available in what are already fairly small sample populations.
I can't really see this helping in the eyes of the FDA. It maybe gets you to Phase III trials a bit quicker.
I say all this to calibrate my expectations for IMUC going forward.
Thoughts anyone?
Murocman
As someone who just broke my own rule and left way too much invested in Celsion, I'd say you take it off either when you have a double or before a binary event like data release or FDA panels, etc. in the end this is about making money and protecting your capital is paramount.
GLTU,
Murocman
There will definitely be a market. It just remains to be seen how broadly this technology is used for pain control. Quite honestly, I think part of the battle will be the simple fact that hospital patients typically get an IV shunt as standard procedure. If it's already there, it might be hard to convince the cost reimbursement side to use a different delivery for pain control.
Given the prevalence of infections contracted in hospitals and the significant increase in risk the an IV creates in this realm, it will be interesting to see if there isn't a re-look at their use.
The is a very good presentation on the ACRX website under the Investors section (1/12/13 is the date I think). It does identify the market potential and several advantages of the system, but has no cost comparison data, which makes me think this solution is more expensive. The question is how much and is the ACRX solution going to be deemed compelling in spite of that?
Those are longer term questions that will get addressed by the FDA and the marketplace. Maybe we can get some practicing health professionals that can comment on some of these factors as well.
Murocman
In reading some other boards/sites(YMB...much as I hate to & SA), it seems there is some doubt as to whether or not there would be a fast/significant uptake because current IV delivery is so cheap and already the SOC. The debate seems to center on the fact that the benefits of the ACRX solution are mostly for nurses (the deliverers) and patients (longer efficacy due to timed absorption due to delivery method), so unless Doctors and more importantly, cost reimbursement entities get behind this, it might be tough sledding.
All that said, this definitely seems to hold the promise of being a much better mousetrap and one would think it would be a no brainer. I have a small position here and may add on weakness heading into the remainder of the Ph III data.
GLTU,
Murocman
Just what is says, I think. If the company releases any data prior to Feb 5, then they would be required to submit an abstract by the normal deadline. They could always ask for an exception, and would probably have a good chance of it being approved if the data is outstanding.
Murocman
FYI ASCO is May 31-Jun 4, 2013 and abstracts are due Feb 5. Late breaking abstracts are due by Apr 1, but in order to qualify, there can't be any preliminary data available before Feb 5. Timing requirements might not work for Celsion.
Murocman
If I was to handicap, I'd look towards ASCO....normally in June.
Murocman
That should be wouldn't vice would in the previous post.
Murocman
This makes me think data release is imminent and the company knows the trial was successful. Otherwise, how would they be able to expand their deal like this with Hisun? It would be good business to give $5m away without knowing that the product you signed up to manufacture works and will be in demand.
GLTA,
Murocman
No more than 8 trading days left based on the company's timeline. I'll bet they have results out by the 28th. Assuming the results are good and they get a big pharma partner, we could see a $1B market cap near-mid term. That equates to a $28 per share price, and where I will start lightening my share load.
GLTA,
Murocman
Below 50 DMA at 7.34. Not that technical indicators are worth much at this point, but would be nice to this close North of that today.
GLTA,
Murocman
FDA has nothing to do with it. This is about the company releasing the results of their trial.
GLTU,
Murocman
No it's not by any stretch. The "arguing" going on here is an intelligent and spirited debate about actual materiel aspects related to the success of this drug trial. That is a HUGE difference from the mindless, uniformed garage that is spewed on YMBs.
GLTU,
Murocman
Wondering how much concern to have regarding the company's waiver request for the dermal carcinogenicity study? Seems like there should be enough data to answer the mail, but have certainly seen the FDA be inflexible with supplemental study requirements on other drugs.
GLTA,
Murocman
It would be nice if this company's executive's put as much time and energy into actually advancing their business rather than pumping their company on every new outlet imaginable and training for ironman triathlons. I hope their New year's resolution is to make some meaningful progress and put out some material news.
GLTA,
Murocman
From what I can gather, the technical file filing is stage 5 of a 6-stage process, with the final stage be labeling. The PR make it sound like they have already done stage 6 and included it so it may be possible to meet the timeline. It was also discussed on the website I got this from that this whole process is essentially a self-certification and the actual "approval" is more or less getting the EU FDA equivalent agency to agree that you have completed the process.
Hope that helps. GLTU,
Murocman
Institutions are driving this train. Will be interesting to see how far they bid this up before it takes a breather.
Murocman
Because it's approaching a major resistance point on the chart. Pending any major news, I wouldn't be surprised to see this churn around this level for a bit.
GLTU,
Murocman
This company will either hit a home run or strikeout....not much in between. There future is based on their ability to use technologies like RFA and HIFU to deliver precise, concentrated doses of proven chemo agents to improve the effectiveness and ultimately the outcomes for patients receiving their treatments.
I liken it to turning an iron bomb into a smart bomb. The key is in the reliability of the delivery mechanism.
Based on the statements from the CEO and the amount of institutional buying there is a lot of confidence as we head to data release.
There are certainly skeptics..always are when you try something new.
It all depends on if you believe in the delivery mechanism and the ability of the company to execute....I do.
GLTU,
Murocman
I certainly agree. I guess what I'm really wondering is if Celsion would even be in a position to effect a partnership with a foreign partner before top line data release? Kinda like poker I guess; they can't show their hand but they want someone to throw a big bet in the pot!
GLTU,
Murocman
A typo....my apologies. If you read the whole post you would have noted that. Anything constructive on the content or so you just hang around to nitpick at typos?
Wondering if Celsion might pull a "Threshold" and ink a deal with a major pharma company before PII results come out?
I was in THLD last Jan when that happened w/Merck and it was a very nice surprise. I know the circumstances are very different here (PIII vice PII) but the CEO did say they were looking to partner outside the U.S. Just thinking we could possibly get a nice Christmas present before we get our New Year's surprise.
Thoughts?
GLTA,
Murocman
Folks are holding tight....selling interest drying up along with the volume.
Good data should be fuel for a nice pop. Major resistance at $0.80.
Murocman
About what I'd expect from a biotech that still has their drug in the trial process. This is pretty much a non-event. It's all about trial results and potential partnerships at this point.
What say you?
Murocman
They don't....this was a trade that occurred earlier in the session that didn't get posted until after the close.
Murocman
That is the big question at this point. I think most people expected this to be around $2 per share pre-approval and move into the $3-4 range post approval.
The events of this week have cast doubt on that scenario. Personally I think we approach $1.20-1.40 pre-approval and move into the $2-2.50 range post approval. If a buyout or significant partnership occurs we could see $3-4 IMO.
GLTU,
Murocman
IMUC contracted out their manufacturing to Progenitor Cell Therapeutics which is already an approved producer of dendritic cells and has multiple clients.
While I agree enrollment can take place, I would think it would be harder and slower without a vaccine to administer.
Murocman
People are all hung up on enrollment numbers. Unless I missed something, the company didn't really have an approved entity that could produce DCVAX in the volume needed to support a large trial until now. Kind of hard to enroll people when you don't have the meds to treat them. I'd bet we start to hear a lot more about enrollment in the next 30-60 days.
GLTA,
Murocman
Next resistance points on the weekly chart are around the $3.50 and $4 levels. It will be instructive to see how the stock acts as we approach these price points and give an indication of how powerful this break out is.
Moving above and staying beyond them on heavy volume will be your sign that the big boys have jumped on the train and are going to take this to a new level. Likewise, if we do pause on lighter volume and consolidate, that is a good sign as well as it indicates the current buyers are holding tight. A reversal on heavy volume would be a short-term sell signal, and buying opportunity on the dip as Bioman already pointed out.
This is the way I see this shaping up and assumes no news. If we do get some kind of positive PR, all bets are off!
GLTA and good trading,
Murocman
Very good point. If the data is compelling, things will happen a lot faster than the "normal" timeline. Assuming the market isn't in the toilet and the world broke, that would be a recipe for some serious price appreciation!
Murocman
Maybe not...if they get topline data in Q4, it will take some time to finish the analysis and get the NDA together. It would expect to see this in late Q1 or early Q2 '13. Even with a priority review, the FDA has six months from the time they file the NDA. They could approve sooner but are not obligated.
GLTU,
Muroman
$0.55-0.60 are the next test levels. 50 DMA is at $0.55 and the next level of resistance is $0.60-0.65. Unless we get news, watch the volume and price with respect to these levels. A move through these levels on heavy volume will confirm the bullish break upwards we saw today.
GLTA,
Murocman
Agree...looks like the next level of resistance is around the $4 level.
GLTA,
Murocman
I agree that it's a bit un-nerving, but $48+M of trading activity is not retail speculation. There is certainly something going on at the institutional level. We will hopefully get clued in early next week.
GLTU,
Murocman
Price target after abstract release tomorrow and going into data release. Thinking the stock could get to $6 on strong data, and would then likely pull back to the $5 range while things get sorted out with Phase III trial(s). Opinions?
GLTA,
Murocman
Seven Trading Days out from the ODAC. As we head into the home stretch to the ODAC, TLON is looking very good. The briefing docs will likely be released on the 19th. Having been through a few of these, the tone of the documents is likely to be negative. That said, it is a matter of degrees, and if there aren't any extremely negative comments or questions regarding safety, efficacy, or trial design, it will likely be received as a positive and the stock is likely to move even higher.
The next thing to for is the panel vote. Again, if it is overwhelmingly positive, or unanimous, the stock is likely to soar even more. The other thing this would do, is significantly increase the odds that the FDA would approve Talon's drug before the PDUFA date IMO. When you put together an SPA, accelerated review, and an overwhelming positive committee vote I think the FDA could act sooner rather than later. Although they didn't face a committee, you can look at what the FDA did with Curis' drug for metastatic BCC as an example. One possible hitch in the analysis above would be the requirement to enroll the first patient in the PIII trial before approval.
If the panel vote were to be close to evenly split, I think we see a sell-off as the uncertainty continues until the PDUFA arrives.
All that said, the data from the trials looks very positive, and the population with this type of cancer is significantly under-served so I'm bullish on the prospects. I plan on holding through the ODAC/PDUFA/approval or $5 whichever comes first.
GLTA,
Murocman
I'm thinking this is not NWBO because they don't have a trial site in Miami, but of interest:
http://video.foxnews.com/v/1473643661001/vaccine-to-fight-brain-cancer/
GLTA,
Murocman
Go to the link below. The presentation is embedded. It will play by itself or you can click the dots underneath to advance the slides.
Murocman
http://www.advaxis.com/news-and-ceo-blog/events-presentations/
see post 1377 and 1379.
GLTU