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It doesn't really matter what anyone says about it... CEO or otherwise... the fact of the matter is that prior to filing the IND AMBS will have to provide data indicating statistical significance regarding reinnervation and dopamine concentrations... the FDA will insist on it... it is easy to make too little of this and too much of it...
What do the data sets of 6 mean since they are not stat sig due to insufficient sample size... it would be making much too much of it to say that this proves anything, because it does not... plain and simple... not matter what anyone wants to believe...
However, it is making too little of it to simply dismiss the findings as irrelevant... the data is promising... if you flipped a coin six times the odds of getting six heads in a row is only 1 in 64... in other words you would likely need to do it about 64 times or so for that to happen... maybe the results regarding reinnervation and dompamine levels were just that one in 64th time when everything looked one way, but really was not... but probably not... it probably is an indication of something good... the only way we find out for sure is to keep flipping coins... or in this case... test some more rat brains... this will happen prior to filing the IND... ind-enabling studies... and when we get the results it will be a very big deal to the scientific community as well as investors...
"The behavioral data achieved statistical significance with a p value of less than 0.03 with animal groups of N=12. The striatum reinnervation data and dopamine concentration data did not achieve statistical significance because the animals sacrificed from the behavioral study were divided into 2 separate groups of N=6 for the analysis of densitometry (striatum reinnervation) and neurochemistry (dopamine concentration in the striatum). The method of analysis of the rat brains did not allow for the densitometry and neurochemistry to be analyzed simultaneously in the same animals, leading to groups of N = 6 or less, which was insufficient to achieve statistical significant."
I have to say I enjoy this period of time in a stock like SBFM... a period for quiet accumulation... you know behind the scenes there is a steady march towards the ind... but not much news... it is a restful regenerative time... enjoy it... this has moved from the twenties not long ago into the forties... without much happening other than completion of some ind-enabling studies... a steady undercurrent... a harbinger of what is to come...
yes... we are learning... it may be difficult to see it now with the negative event still fresh, but in the long-run this lesson will most likely make us many times over what it cost us... in that sense i do believe it will prove quite valuable to all those who continue to invest in this most intriguing sector...
There are legitimate risks in this sector for investors... but the use of words like "fraud" and "scam" are way over the top and little more than obfuscate...
This is very good and will indeed drive the price higher... it will take awhile to complete ind-enabling studies, then the ind application, then approval by the fda, then initiation of the p1 clinical trial... pps will rise a bit with the announcement of each of these... so investors should not be expecting a quick hike based on this information... the fda process takes time...
Hopefully, management will build in an efficacy endpoint into the p1 trial even though the primary goal of p1 will be to check safety and assess dosing limits in human beings...
I'm too cheap to pay for private messaging, but I do appreciate your response...
I think the "float is locked" can be overdone... especially with the phantom shares... and in theory they should have to be covered at some point, but they often just get shuffled around in reality... AMBS' name change experience is a case in point about a time when those shares really did have to be accounted for and the pps rose...
Nonetheless, I agree with the general idea that during these recent periods of consolidation that more and more of the float is ending up in the hands of longer horizon investors... the shares I have been purchasing fall into that category... over time the float does get tighter and with good news and a corresponding spike in volume the pps will be driven up...
I am not the least bit worried about current fluctuations in pps during this period of consolidation... it means nothing to a long horizon investor other than it provides some nice price points for accumulation...
so in general I agree with you regarding trend... however, the float is locked so we will see a sudden spike... I am doubtful..
I do think we will continue to see a promising trend of higher highs and higher lows as we continue upward and onward...
Of course a big partnership announcement or buyout would change that scenario quickly and drive pps rapidly... glty...
kinda difficult to lock a float when phantom shares can be created in various exchanges through naked short selling...
Average volume recently has been 440,000 or so... I doubt what gets posted here has much bearing on the pps... this is a great stock with a pipeline that has truly awesome potential in a very early phase of development in a highly speculative sector... there are reasons to be very optimistic... there are also reasons to be a bit cautious... all points of view here have been reasonably argued in my opinion... no need really to speculate on the motives of various posters...
I think we have been in a period of consolidation here for a bit... which is quite healthy... and look for the next run to begin soon fueled by positive news events... look for another spike in volume to signal it... and when it happens I think the march towards $3 will be on... evidence of 21 bio-marker in March could well be the catalyst to take us there... in the mean time if you want any more this is the time at this current plateau...
A link to an interesting 4 minute video regarding GDNF in a French hospital... with a couple of patients... if GDNF can do this and MANF is better... then wow... this needs to keep moving towards the market place...
Dr. Jerry thank you for your thoughtful and informative posts... it raised my curiosity and caused me to do a little digging... fascinating story... ran across these tidbits from trial participants... all very anecdotal... but humanly compelling...
excerpts from
http://www.pdpipeline.org/2011/GDNF/gdnf_resp_participants.htm
Only weeks after he began receiving GDNF in April 2004, Robert Suthers, 69, noticed dramatic improvement in his PD symptoms. “I could go out for dinner without fear of stumbling. I could write again. I had my life back,” he said.
Then in September, Amgen, halted the clinical trial, and took away Suthers’ access to GDNF. His pumps haven't been refilled since summer, and he feels his symptoms worsening again.
“We'll sign away on the risks for the benefits,” said Suthers, who suffered a seizure following the first surgery, and then a stroke. “I want the drug. We are desperate. It's not fair to take something away that is helping people.” (1)
Steve Kaufman, 50, has had PD for 10 years, and says he “couldn't even hold a nail stable” before he began taking GDNF. The drug allowed him to build new kitchen cabinets and an outdoor deck. After several weeks off the drug, he already feels his stamina slipping and his shaking becoming more pronounced. "I don't think we were given a fair chance," Kaufman said. "It's almost the same thing as a diabetic losing their insulin." (2)
Robert Green agrees. "When I signed on, my wife was lifting me in and out of bed," said Green, diagnosed with Parkinson's 14 years ago at age 36. After the surgery, when the pump was filled with GDNF, he said, "things got progressively easier” and “I was almost self-sustained again. It was a wonderful feeling.” Now, after a few months without the drug, the weakness in his legs is returning, and his wife has to help dress him again.
Another family told Amgen how GDNF allowed their mother to shop, dance and go on vacation for the first time in three years. “GDNF deserves more time, and so does our mother,” they wrote. (2)
(1) Talan, Jamie. “Drug trial – and error?” Newsday, November 22, 2004.
(2) Pollack, Andrew. “Many See Hope in Parkinson's Drug Pulled From Testing.” New York Times, November 26, 2004.
Bio... I made taking my basis off one of my rules in large part because you drummed it into my head over on the CL_N investing board... I thank you for that... it kept 1/31 from being a disaster for me... painful yes, disaster no...
LOL... "what made you sell out at the optimum time"... I wish... that is far too great a claim for me when it comes to CL..
I am ready to move on from CL.. but before I do let me take a moment to answer your question clearly... I did not sell out at the optimum time... I sold enough shares in November and December (remember at the time all we knew was that the binary event would occur sometime in January) so that I locked in enough profits to cover my basis (my original investment in CL..)... I held the rest of my shares through the binary event... ouch... so when I closed out my CL.. holdings on 1/31 I essentially broke even on that stock...
What I lost on 1/31 were "paper" profits that I could have locked in had I known... it was, of course, painful to see those profits evaporate in mere seconds... poof... they are gone...
In the bigger picture... financially in regards to CL.. I am not worse off than before, but not better off either... although the lesson learned may well prove quite valuable moving forward and help me avoid even bigger, costlier mistakes in the future...
So what made me take my basis off? I took it off because it is one of my rules... I made it one of my rules on the basis of guidance from more experienced investors including Biomanbaba who says "Always take your basis and you will never lose your arse." I am grateful to all those more experienced investors who drummed this into my head because it kept a painful event from becoming a disastrous event for me. I am now updating my rules... and now in addition to my basis I think I will always take a significant portion of my profits as well as my basis pre-binary... perhaps at least 50%... live and learn...
As others have said... create reasoned investing rules for yourself... and follow them... whether you want to or not... your rules will keep you from disaster...
Interestingly enough when I took my basis off for CL.. I rolled many of those dollars into CTIX... my holdings in CTIX are an enormous comfort to me now and give me hope that I can recover the value in my portfolio on the way to even higher gains...
Bio... that was a tough day to be sure... a real kick in the gut... good to see you right back in the saddle... the market is brutal... but it can also be forgiving in the sense that fortunes can and are lost, but can also be re-made... time to focus on the re-making...
great post... excellent pr... good way to end the work week and begin the weekend...
I too am in the take your basis off the table club... and if you set your price too high such that you don't take your basis until after the risk event then you have missed the point of taking your basis all together... the market is a living, breathing thing... it won't always give you the price you want... I am in agreement with others that there does not appear to be a significant risk on the immediate horizon for CTIX... I am not hedged at all yet even though I have some significant profit from my earliest CTIX shares... but it makes no sense to say I won't take my basis until $51.53... you take it when you are able prior to a significant risk event at the price the market will give you whatever that is... imo...
With CL.. I set a target to take my basis off at $10-12... but the market did not give me that... so I took it off in late November and early December at mid-sevens to mid-eights... if I had waited until it reached my target price I would have lost much more...
The VA as well as the DoD will be watching this closely... after many years of war... TBI is a major issues...
LOL... playing games... that is what? a $20 transaction...
Thanks Looping... good to see you here too... being wrong is being human... own it, learn from it, get up, dust off and right back at it...
If anyone needs perspective... just consider this... yesterday I lost a signficant profit... vanished in seconds... yesterday someone, somewhere was diagnosed with HCC... there is bad news and then there is BAD news... I feel worst today for those who need an soc for hcc... the world needs kevetrin to be an answer for cancer... that doesn't mean it will be, but it is greatly needed...
your rules will save you... my rules saved me from disaster yesterday... and i can tell you when i followed them in november and december... selling shares to cover my basis... i did not want to... i did it fighting with myself the whole way... many of those dollars were rolled into ctix... do you think i am glad today that i did that? but i wasn't happy about it at the time, so strong was my thought that the other stock would have a successful outcome to p3 and i would lose profit opportunity by selling then...
i agree with your analysis... another stock sbf... which also involved mutual investors in these companies has struggled today for no fundamental financial reason... i think the residual effect will last only a few days at the most and then be gone... it is not fundamental to the investment thesis... and as others have said each stock is very different... and should be evaluated individually... this has created a buying opportunity for any willing to wade into the waters... i have done some buying today... i think these prices will soon be relegated to history... for ctix... and sb...
You are correct. Psychologically speaking I can say fear is our strongest emotion and with it the requisite desire to avoid pain sometimes at all costs... anger is a close second and sometimes gets mixed in with fear... both emotions can hijack the amygdala triggering the fight, flight or freeze survival response... when this happens brain scans indicate that activity in the cerebral cortex is reduced significantly thus impairing our ability to reason... Investing is a psychological game... the ability to buy low requires one to override this basic survival instinct and buy a stock when it is in the red as others are selling... fear drives a considerable amount of market activity...
yes... and with better analysis comes better decision and with better decisions... we make more money... all to the good...
super, your dialogue with joboggi was helpful to me in conducting dd... and prompted me to learn about a-syn, protein misfolding and chaperone proteins... along the way i found an article from 2009 i think in which a researcher was looking for chaperone proteins... guess who her funder was? i'll give you three guesses and if one of them is pfe, then you got it right... so pfizer has been interested in this space for awhile now... does not mean anything gets done... but it is a tantilizing tidbit to speculate on...
it is just as unfair in my opinion to label a person who makes a reasoned argument for a stock as a pumper as it is to label a person with a concern as a basher...
we know pumpers and bashers by their content... which is sparse... all my opinion of course...
thank you... i think we need more categories on these message boards than just pumpers and bashers... in order to achieve reasoned conversations about the pros and cons of investing in this highly speculative sector... there is a great deal to like with AMBS as well as a good deal to not like so much... I want to hear from reasoned investors from both sides... pumpers and bashers are both as noise to me...
Well said... I have taken a position... the question as to whether I am brave or foolish for doing so remains to be answered...
Agreed. You offer a reasoned contrarian opinion which to me as an investor in AMBS is extremely helpful. Keep posting please. When honest contrarian views are dismissed as bashing, then we will have entered the world of groupthink... out of which many disasterous decisions have been made...
Good post... you are correct many significant achievements have contributed to the rise in pps since May... funny how good news is always trumpeted as pumping in biotech land...
I do understand the skiddishness of investors after yesterday though... I sold enough to cover my basis in CL... back in December... so what I lost yesterday were profits I could have had... painful, but not devastating... I sold out immediately and have moved on...
It is painfully funny to me to see the "know it all" takes of everyone weighing in after the fact now that all the information is in... I am glad for those who avoided the pain, and wish the best to all those who did not...
The simple reality is we make these decisions knowing only so much... even management isn't able to know the outcome, so how can a retail investor far removed from the activity... there are two ways to interpret almost every event and news item in biotech land and committed longs and shorts with almost everyone of these stocks... we invest in a risky sector with finite knowledge... don't kid yourself... and always take care of your basis when you have the opportunity... I am very glad I did at least that much...
Would I do it again... probably... I suffered the loss of gains I might have had, for the sake of a possible multipe several times that... the risk/reward made sense pre-data... and in truth when I stop to think about it still makes sense post-data... but I understand why someone might sell today... it makes you question all your investment decisions...
I am long CTIX... put a good bit of my CL.. basis into CTIX last fall... added a little more yesterday... will add some more to a roth next week... the science looks good, but then again I have said that before... eyes wide open... try, try again...
Yes it is.
Time to move on... No one placed the buy order for anyone else... we all made our choices and took our shots... painful ending to an otherwise worthwhile experience... I thank everyone on this board for your contributions and may well see you elsewhere on these boards... I am certainly not finished... onward and hopefully upward...
As for Celsion... it pursued the noblest of goals... nothing wrong with its mission... obviously a flaw in the implementation... sadly shorts and primary liver cancer won... the shorts I can live with... liver cancer not so much...
I don't mind shorts... however, people who revel in the pain and misery of others are another matter... I pity those who gloat today... you are doomed to live a small life...
Finally this... I did not see this coming at all... so when I clicked on the PR around 7:00 am and saw that T-dox failed to meet its endpoint it was a kick in the gut... now imagine that if instead of getting this news about my stock I was sitting in my oncologist's office and he just delivered the news that I was dx'ed with HCC... there is bad news and then there is BAD news...
That is a crystal ball with a serious sense of humor... let's call his crystal ball "Loki"...
It will be forward splits with a split adjusted pps in the triple digits...
LOL... safety issue... too funny... let's think about this one for a moment... it's not like Doxorubicin is new to the FDA... far from it... it's safety/risk profile is very well known... and it has been approved for and used in treatment for cancer for many, many years... in much higher doses than in T-dox... Doxorubicin is in fact toxic... so Randy here is asking us to believe that a drug which the FDA has approved for use in spite of its toxicity will in fact now be considered somehow unsafe when administered in lesser amounts which in fact will make it safer and far less toxic than free Dox...
T-dox has passed something like half a dozen safety reviews with the DMC and been unanimously approved for continuation each time...
Please... the least of our concerns tomorrow are the safety issues...
RFA like Doxorubicin is a well known procedure used safely as a standard of care... move along... nothing to see here...
I have been amazed at the constant hammering of negative spin... gotta hand it to the dedicated hoard... I think the reason it works is because it appeals to our base emotion of fear... it is easier to instill fear, than it is to encourage hope... the only way one survives in this kind of investing environment is to know your investment thesis so well that it becomes the rock that anchors you when chaos ensues... attempts to spin this cc as negative are just hilarious to me... only a management team of fools would create all this notoriety just so they could go in front of the camera and say... ooops... T-dox failed... a-huh, a-huh...
This management team is wicked smart... they gave us the Hisun deal with upfront 5 million shortly after the manipulation of the million share market dump... then they waited until the very last day of the month... building suspense with every day, while negotiating with other partner candidates... reports of officials from Merck and Pfizer making their way to Lawrenceville offices... and now that the suspense has boiled to a roiling top... they schedule the lights, action, cameras... they did not mastermind this plot to look like jesters in the kings court... they did it to look like kings... fear not... good news rises with the sun tomorrow...
That says it all doesn't it... great post...
Yes... they would have to be crazy to handle bad data in this manner... and they are not... good news straight ahead... make no mistake... the only remaining question is... good news or great news...
LOL... I never would have thought when management promised data in January they meant the absolute very last day in January, but apparently that is what it has come down to... looks to me like it will be the 31st... the good news is all signs point to stat sig... building this kind of drama would be a completely insane way to try and bury bad news... tomorrow more and more eyes will be focused on CLSN when the do the great unvailing... it has been a strained wait... but tomorrow it will all be worth it... imo...
panic without merit provides opportunity to investors with the knowledge, experience and courage to take advantage... i wouldn't mind a little panic... but i doubt very much that those who have come this far would panic over such a little thing... imo...
It is remarkable how the closer we get to results, the more there are various parties which attempt to obfuscate with old information, immaterial information and wild fantasies about possible disaster scenarios... this will continue after results as well... keep your eye on the prize and remember that you invested in the science... data is so very, very close...
Great post...
highly unlikely imo... but I appreciate the explanation...
Ok... let me rephrase...
Seriously? What evidence do you have to back this wild hare notion that someone might be going to jail? Please do tell?
Seriously? What evidence do you have to back this wild hare notion that someone will be going to jail? Please do tell?