You can have good science with negative results, and bad science with positive results. The reason for the flawed science is outlined above. Look at my previous comments in other SA articles - the reason for the flawed science was noted in those - time and date stamped.
I'm glad you made money and you surmised that something was amiss based on the conference. But if the conference issue had not come up, you may have been in the same boat as the other longs.
My point here is that the science is what matters most, not these other issues. If the goal here is to decrease likelihood of this happening to you or other investors, then it's always best to evaluate the science as best as possible and rely on that as your crux.
A few weeks before ACAD announced successful results, Adam F came out with an article bashing it re it's stock offering and the way they went about doing it - shedding a very negative tone on the stock. I believed in the science and held thru. A few days before SRPT took off from 15 to 45, it shed a few dollars as everyone started to bail on it - again all emotions as the results were positive. I again, held thru.
Point is, there are ups and downs with all these stocks, but relying on the integrity of the science is what will increase likelihood of long term success and highest chances for success. Can't win them all...
Thanks for the article and for talking about this in the open. It does help to look back at these events in hopes of improving ones experience for the future.
Last point: It wasn't my intention to sound condescending in my first response - if it came off that way, my apologies. But using "Duh" in your response back really doesn't help your point and just detracts from the conversation. No hard feelings...
4 Small Biotechs With Big Clinical Trials Presenting In 2013 [View article]
Venaxis' company history remains a major problem for this stock. So far, the stock has been bouncing between 2 and 3 the last few months, and has wild swings because of the low float. Looking at the recent data and the fact that CE mark was approved, I'm hopeful that the next phase trial will duplicate the already-known results. I can tell you that if this test turns out to be as good as the data already shows, it WILL be adopted. The cost of this test at $80 is nothing compared to the cost of avoiding a CT scan. Furthermore, there is a HUGE push in the pediatric population to minimize CT use given recent cancer data. Accordingly, everyone is looking for quick tests just like this.
I'm sorry but I just don't buy your reasoning. First, I'd like to say that I had no stake in this company when data was announced.
Your first two reasons are speculative and only reflect on the outcome in hindsight. Looking forward, these two events wouldn't logically make anyone want to sell.
Your 3rd point about a bear raid is also misleading. Someone bought 9000 in the money call options a few hours before the plunge - I noticed this on my screen and thought it was suspicious. Someone else broke down this sneaky trade. A few hours after the options were traded, the bear raid occurred. Likely this trader exercised his options, sold all the shares in one fell swoop. On it's way down, multiple stop losses and low bid limits were activated and the stock plunged. Under all those bids, there was a huge limit order sitting on the bid around 6 ish for 600+K shares. This guy then bot a ton of shares for extremely cheap and probably made a killing in the next few days as he sold his shares.
Again, this should have no bearing on whether the study met it's end point. These studies are blinded and very few have access to the data, including the insiders who bought stock like crazy.
Re the AF rule - this drug, it's mode of delivery, and mechanism of action was very different from all those other trials.
How about some real warning signs: How in the world is thermodox which exerts its effect at the site of a RFA-treated tumor going to prevent development of other intrahepatic mets? I could never answer this question satisfactorily... this was the big warning sign that I waived on SA in other comments.
Overall, I feel bad for all the longs - I feel bad for the cancer patients who cannot receive this treatment, and I feel bad for the company. This just sucks for everyone. However, the warning signs were not what happened to the stock or the company's cancellation of a meeting. Without any real data, the stock moved in many directions because of two basic human emotions: fear and greed.
Ultimately, in my opinion, the science was flawed.
Celsion's Phase III Blockbuster Data Revealed And It's Been Right Underneath Your Nose - Part 2 [View article]
right... my point exactly. you can't really base your RFA only PFS outcomes on the data that you have. i'm not saying my analysis is valid, i'm just saying that the numbers change substantially based on what you plug in as your baseline RFA only PFS expected outcome. the numbers in the literature are mostly for small tumors... very few out there for larger ones and they are all mixed up anyway. i'm just saying that we are in a data-free zone and you can't jump into conclusions such as the ones you are making. it's not really that clear cut. i'm not a bull or a bear... and certainly, i would prefer that the drug works for all the patients out there who need it. however, from an objective perspective, i don't think it's as simple as your article notes.
Celsion's Phase III Blockbuster Data Revealed And It's Been Right Underneath Your Nose - Part 2 [View article]
Hi Alex,
I'm sorry if I was not clear. I don't doubt the released data whatsoever. I do question your assumptions, however, about the PFS in patients who are treated with RFA alone. Based on reviewing the paper that you quote, there are a few problems that I noticed. Firstly, this paper only has 40 patients. Secondly, they treat tumors less than 3.5 cm in diameter (TDox trial is for patients with greater than 3 cm tumors). And lastly, their PFS results are absolutely dismal as compared to the literature quoted rates for tumors of the same size. Most articles that I have read quote a 3 year PFS for RFA in small tumors (less than 3 cm) of about 50%. These investigators quote 20%. So, overall, I question the integrity of the data (ie the paper) upon which you base your assumptions for what the PFS SHOULD be in patients treated with RFA alone.
Having said that, I spent about 4-5 hours yesterday and today to try to find articles that would quote a baseline rate of PFS for RFA alone treated lesions greater than 3 cm but less than 7 cm (equivalent to TDox trial). However, this is very difficult to find - likely because these tumors are not successfully treated with RFA and so rates are lower. How low? I don't really know.
I did find one paper Peng, et. al. EJSO 36 (2010) 257-263 which had treated patients with tumors less than 7 cm (total of 120 with RFA). I don't think this data would necessarily parallel the Tdox data but it's the closest I could find. They found PFS 76%, 60%, 47%, 30% for 1, 2, 3, and 5 years respectively. I plugged these numbers in for the data that you provided and came up with a PFS for RFA only group of 61%!!!! That is WAY off the mark.
According to what I've read, the trial needs a 33% difference in PFS between the two groups to be considered successful. If you just play with the numbers a bit, you can easily calculate that this would require the PFS in the RFA group to be less than 38%. This would make the PFS in the RFA-Tdox group be about 51% (which is 1.33 x 38).
I really don't know what the results of the trial are going to be. I just want to point out that relying on previous data to assess baseline PFS for RFA only group is likely to be inconsistent and a stretch at best - as there is very little data and most of it is poor.
Celsion's Phase III Blockbuster Data Revealed And It's Been Right Underneath Your Nose - Part 2 [View article]
honestly, if the analysis of 'what should be' were that easy, they wouldn't need to do clinical trials. be mindful that the data that you present as 'should be' rarely actually ends up being what 'is'. your assumption is that the RFA only group will perform the same as all other RFA-only groups and that may not be so.
be mindful that most of these clinical studies are powered 80% - that means that there's still a 20% chance that even if the drug were highly effective, the data would not show it. the bar to demonstrate effectiveness is set super high in all clinical studies (versus a 5% chance that if the results were positive, they would be due purely to randomness). statistically, it makes more sense to give odds of success a lower rating (have to consider baseline rate of cancer drugs that show effectiveness in phase III trials - which is low). but the key to investing is considering odds of success AND payoff. this stock had a great potential payoff * odds of success multiple when it was 5 bucks. now, i'm not so sure. you do your own math to come up with where you think it may end up if it's successful - but make sure you account for the fact that your probability for success are already down 20%.
Celsion's HEAT Study: A Far From Certain Outcome [View article]
The BIGGEST problem with this study is presence of non-detectable intrahepatic disease (whether they are truly mets or simultaneous other primary tumors that can occur in HCC). It makes good, logical sense that T-dox+RFA will more effectively kill directly targeted tumors. The zone of the 'blast' will be larger because doxorubicin will destroy any peripheral cells in the blast radius of the RFA.
The big question to ask yourself is how is the doxorubicin in the T-dox liposome going to get to these extra sites of disease and actually be there long enough to act on these? This does not make logical sense to me... Even if doxo washes into the blood stream, it is quickly washed out into the portal and hepatic veins and into the main circulation. I can see it hanging out near the directly treated tumor, but can't see how it goes to these other sites.
If there's quiescent tumor in the left lobe, how's treating a tumor in the right lobe with Tdox+RFA going to treat this other tumor. Simple answer: it is not!
The only way that this trial will be successful is if there is such a tremendous response of tumors to local therapy; and such a low local recurrence rate that it would make up for the baseline appearance of disease elsewhere. From studies, we know, however, that 2 years after treatment with RFA for HCC tumors, the greatest % of disease is from sites other than the previously treated tumors.
I was a huge Tdox fan and I got in way early - but recently, as I've poured over the data more, I've become more bearish.
If you're going long, only play with money you're willing to lose. If you're going short, consider buying puts alone or shorting the stock with protective calls. There's will be a huge directional change in this stock. If you are experienced with options, the best way to make money is a play on volatility crush.
Celsion: Breaking Down A Biotech Winner [View article]
I agree with the other commentators. I have been long with options for many months now - and more recently scaled back some of my options to create a near risk-free position (still holding calls) going into results. However, though I agree that holding positions through results is risky, I would suggest that 'investing' in the earlier days was more risky. Why? Trial mishaps, secondaries, you name it. I would argue that now is as good (or better) a time as any to get into this game with options. Even the insiders got in late in the game: Tarungo with purchases in the 5's and Max Link who bought 100K worth of stock at $7.60. As you note, the full potential of this company is not even close to being realized. With a few deep out of the money calls, one can keep risk very well controlled. With a well-timed reverse calendar, one can almost guarantee profits.
5 Reasons To Be Bullish On Celsion Now [View article]
With the exception of a few bullish statements by the company about their balance sheet over the last conference call, and their 'promise' to have data ready by January, very little has changed here. The last few months of ups/downs are typical market emotions, fear, and greed. The recent upward climb of this stock is as illogical as its slow bleed earlier. I remain long.
Galena Biopharma: Catalysts Have Led Its Stock Higher [View article]
You should point out that the improvement seen in the subgroup may be due exclusively to Herceptin. More patients who responded were on Herceptin than those who didn't.
Galena Biopharma: Catalysts Have Led Its Stock Higher [View article]
From someone who has read every single published article on Neuvax and who is not long or short this stock, I would offer the opinion that there are a lot of warning signs about this drug failing in the long term. Many of these issues are pointed out in the Propthink article and AF articles in the past. Another red flag that no one else has looked at is that the subgroup of patients (increased boosters) who had better results also had more patients treated with Herceptin. In other words, the increased numbers can be accounted for simply by the effect of Herceptin, not Neuvax.
Apple's Innovation Is Stronger Than Ever, Valuation Very Attractive [View article]
Here's what I see re tech stocks:
AMZN - way overvalued with PE in the 2000 range. Why? Promise of future revenues by revolutionizing internet commerce. Any new products? Anything innovative over past two years? Is the promise being fulfilled? Nope. Stealing ideas from Apple re tablet and losing money hand over fist.
FB - way overvalued with PE about 100. Why? Promise of future revenues by somehow using its gazillion users to make money. We don't know how, but somehow they will. Any new innovations recently? Nope - just constantly tweeking the same ol' site. Jumping on the mobile bandwagon.
Apple - PE of 13 now and forward PE less than 10. Why? Innovation must be over at Apple because they haven't come up with anything new in 2 years. Even though they have a history of game-changing innovation that has rocked the world. Because we haven't seen anything else, there must NOT be anything else, right? They have all this cash, and they are just sitting around and thinking about how to incrementally make things better, and that's it, right? Steve Jobs didn't sit down with them and plan out the next 10 years of innovation before he died, right? We haven't seen it so it must not exist.
Look at the facts and the history. Who would you bet on?
Celsion's 'Bad Beat' : 4 'Tells' That Longs Missed [View article]
I'm glad you made money and you surmised that something was amiss based on the conference. But if the conference issue had not come up, you may have been in the same boat as the other longs.
My point here is that the science is what matters most, not these other issues. If the goal here is to decrease likelihood of this happening to you or other investors, then it's always best to evaluate the science as best as possible and rely on that as your crux.
A few weeks before ACAD announced successful results, Adam F came out with an article bashing it re it's stock offering and the way they went about doing it - shedding a very negative tone on the stock. I believed in the science and held thru. A few days before SRPT took off from 15 to 45, it shed a few dollars as everyone started to bail on it - again all emotions as the results were positive. I again, held thru.
Point is, there are ups and downs with all these stocks, but relying on the integrity of the science is what will increase likelihood of long term success and highest chances for success. Can't win them all...
Thanks for the article and for talking about this in the open. It does help to look back at these events in hopes of improving ones experience for the future.
Last point: It wasn't my intention to sound condescending in my first response - if it came off that way, my apologies. But using "Duh" in your response back really doesn't help your point and just detracts from the conversation. No hard feelings...
4 Small Biotechs With Big Clinical Trials Presenting In 2013 [View article]
Celsion's 'Bad Beat' : 4 'Tells' That Longs Missed [View article]
Your first two reasons are speculative and only reflect on the outcome in hindsight. Looking forward, these two events wouldn't logically make anyone want to sell.
Your 3rd point about a bear raid is also misleading. Someone bought 9000 in the money call options a few hours before the plunge - I noticed this on my screen and thought it was suspicious. Someone else broke down this sneaky trade. A few hours after the options were traded, the bear raid occurred. Likely this trader exercised his options, sold all the shares in one fell swoop. On it's way down, multiple stop losses and low bid limits were activated and the stock plunged. Under all those bids, there was a huge limit order sitting on the bid around 6 ish for 600+K shares. This guy then bot a ton of shares for extremely cheap and probably made a killing in the next few days as he sold his shares.
Again, this should have no bearing on whether the study met it's end point. These studies are blinded and very few have access to the data, including the insiders who bought stock like crazy.
Re the AF rule - this drug, it's mode of delivery, and mechanism of action was very different from all those other trials.
How about some real warning signs: How in the world is thermodox which exerts its effect at the site of a RFA-treated tumor going to prevent development of other intrahepatic mets? I could never answer this question satisfactorily... this was the big warning sign that I waived on SA in other comments.
Overall, I feel bad for all the longs - I feel bad for the cancer patients who cannot receive this treatment, and I feel bad for the company. This just sucks for everyone. However, the warning signs were not what happened to the stock or the company's cancellation of a meeting. Without any real data, the stock moved in many directions because of two basic human emotions: fear and greed.
Ultimately, in my opinion, the science was flawed.
Celsion's Phase III Blockbuster Data Revealed And It's Been Right Underneath Your Nose - Part 2 [View article]
Celsion's Phase III Blockbuster Data Revealed And It's Been Right Underneath Your Nose - Part 2 [View article]
Celsion's Phase III Blockbuster Data Revealed And It's Been Right Underneath Your Nose - Part 2 [View article]
I'm sorry if I was not clear. I don't doubt the released data whatsoever. I do question your assumptions, however, about the PFS in patients who are treated with RFA alone. Based on reviewing the paper that you quote, there are a few problems that I noticed. Firstly, this paper only has 40 patients. Secondly, they treat tumors less than 3.5 cm in diameter (TDox trial is for patients with greater than 3 cm tumors). And lastly, their PFS results are absolutely dismal as compared to the literature quoted rates for tumors of the same size. Most articles that I have read quote a 3 year PFS for RFA in small tumors (less than 3 cm) of about 50%. These investigators quote 20%. So, overall, I question the integrity of the data (ie the paper) upon which you base your assumptions for what the PFS SHOULD be in patients treated with RFA alone.
Having said that, I spent about 4-5 hours yesterday and today to try to find articles that would quote a baseline rate of PFS for RFA alone treated lesions greater than 3 cm but less than 7 cm (equivalent to TDox trial). However, this is very difficult to find - likely because these tumors are not successfully treated with RFA and so rates are lower. How low? I don't really know.
I did find one paper Peng, et. al. EJSO 36 (2010) 257-263 which had treated patients with tumors less than 7 cm (total of 120 with RFA). I don't think this data would necessarily parallel the Tdox data but it's the closest I could find. They found PFS 76%, 60%, 47%, 30% for 1, 2, 3, and 5 years respectively. I plugged these numbers in for the data that you provided and came up with a PFS for RFA only group of 61%!!!! That is WAY off the mark.
According to what I've read, the trial needs a 33% difference in PFS between the two groups to be considered successful. If you just play with the numbers a bit, you can easily calculate that this would require the PFS in the RFA group to be less than 38%. This would make the PFS in the RFA-Tdox group be about 51% (which is 1.33 x 38).
I really don't know what the results of the trial are going to be. I just want to point out that relying on previous data to assess baseline PFS for RFA only group is likely to be inconsistent and a stretch at best - as there is very little data and most of it is poor.
Celsion's Phase III Blockbuster Data Revealed And It's Been Right Underneath Your Nose - Part 2 [View article]
be mindful that most of these clinical studies are powered 80% - that means that there's still a 20% chance that even if the drug were highly effective, the data would not show it. the bar to demonstrate effectiveness is set super high in all clinical studies (versus a 5% chance that if the results were positive, they would be due purely to randomness). statistically, it makes more sense to give odds of success a lower rating (have to consider baseline rate of cancer drugs that show effectiveness in phase III trials - which is low). but the key to investing is considering odds of success AND payoff. this stock had a great potential payoff * odds of success multiple when it was 5 bucks. now, i'm not so sure. you do your own math to come up with where you think it may end up if it's successful - but make sure you account for the fact that your probability for success are already down 20%.
Celsion's HEAT Study: A Far From Certain Outcome [View article]
The big question to ask yourself is how is the doxorubicin in the T-dox liposome going to get to these extra sites of disease and actually be there long enough to act on these? This does not make logical sense to me... Even if doxo washes into the blood stream, it is quickly washed out into the portal and hepatic veins and into the main circulation. I can see it hanging out near the directly treated tumor, but can't see how it goes to these other sites.
If there's quiescent tumor in the left lobe, how's treating a tumor in the right lobe with Tdox+RFA going to treat this other tumor. Simple answer: it is not!
The only way that this trial will be successful is if there is such a tremendous response of tumors to local therapy; and such a low local recurrence rate that it would make up for the baseline appearance of disease elsewhere. From studies, we know, however, that 2 years after treatment with RFA for HCC tumors, the greatest % of disease is from sites other than the previously treated tumors.
I was a huge Tdox fan and I got in way early - but recently, as I've poured over the data more, I've become more bearish.
If you're going long, only play with money you're willing to lose. If you're going short, consider buying puts alone or shorting the stock with protective calls. There's will be a huge directional change in this stock. If you are experienced with options, the best way to make money is a play on volatility crush.
Celsion: Breaking Down A Biotech Winner [View article]
Fight Your Fear. Buy Bargains. [View article]
5 Reasons To Be Bullish On Celsion Now [View article]
Galena Biopharma: Catalysts Have Led Its Stock Higher [View article]
Galena Biopharma: Catalysts Have Led Its Stock Higher [View article]
Apple's Innovation Is Stronger Than Ever, Valuation Very Attractive [View article]
AMZN - way overvalued with PE in the 2000 range. Why? Promise of future revenues by revolutionizing internet commerce. Any new products? Anything innovative over past two years? Is the promise being fulfilled? Nope. Stealing ideas from Apple re tablet and losing money hand over fist.
FB - way overvalued with PE about 100. Why? Promise of future revenues by somehow using its gazillion users to make money. We don't know how, but somehow they will. Any new innovations recently? Nope - just constantly tweeking the same ol' site. Jumping on the mobile bandwagon.
Apple - PE of 13 now and forward PE less than 10. Why? Innovation must be over at Apple because they haven't come up with anything new in 2 years. Even though they have a history of game-changing innovation that has rocked the world. Because we haven't seen anything else, there must NOT be anything else, right? They have all this cash, and they are just sitting around and thinking about how to incrementally make things better, and that's it, right? Steve Jobs didn't sit down with them and plan out the next 10 years of innovation before he died, right? We haven't seen it so it must not exist.
Look at the facts and the history. Who would you bet on?
Skullcandy: A Stock Ready To Pop [View article]