Neostem is 9 months away from releasing its results of its randomized Double Blind Placebo Controlled Phase II Trial of Intra-coronary Infusion of AMR-001, a Bone Marrow Derived Autologous CD34+ Selected Cell Product, in Patients With Acute Myocardial Infarction.....
This study is assessing the safety and efficacy of intracoronary artery administered autologous bone marrow derived stem cells in subjects post ST segment elevation myocardial infarction (STEMI). Efficacy will be assessed by evaluating and comparing the autologous stem cell treatment group to the control group via change in myocardial perfusion (RTSS) measured quantitatively by gated single photon emission computed tomography myocardial perfusion imaging (gated SPECT MPI) among other secondary endpoints measured by cardiac MRI in addition to clinical endpoints.
Folks, they are not making widgets.... There are close to 60 medical locations across the country that NBS has partnered with for this trial..... This is extremely complicated and complex....
And you want the stock to go up.... just because that's what you want.
Everyone wants to attack CEO Robin Smith, she is running a complex business with a future that has high degree of uncertainty, lots of which is out of her control..... You loved her last June when the stock went from .30 to .70 .... now she is no good because its back in the .50's.... this isn''t fantasy football where you can toss leadership around likes its on the waiver wire. Really 8 months...
Nobody trading is "in the know". That would constitute a major SEC violation. It was an external review meaning they had a team of probably 3-4 esteemed specialist physicians on the DSMB assessing the safety (MACE, serious adverse events, adverse events, labs, vital signs, etc.) between AMR-001 and Placebo and the physicians had no concerns. The data processing and unblinding on treatment groups would be outsourced as well so that Neostem has no knowledge. The data summaries for the DSMB would be in 2 columns. Occasionally those columns might say Treatment A and Treatment B and they assess if there are any large differences. However, the columns usually say AMR-001 and Placebo so the % event rates are transparent. Signed disclosures and confidentality agreements are standard. Any phyisician on the DSMB or any employee on the outsourcing team who trades stock based on unblind information would be in SEC violation in my opinion.
I think not, but anything is possible! I feel it is too early for knowledge of AMR-001. I believe it would be more likely the similar (but not the same) MI trial with BAX are not hitting aspired endpoints. (Keep in mind that AMR-001 is markedly different to BAX's trial. Additional cells are being used in NBS trials in conjunction with CD34+ cells being used in both trials. So regardless of success or downfall of the BAX trial we have a unique and stand alone trial.)
From discussions to date, all of which are speculative, I believe we are experiencing MM's shaking the tree ahead of earnings and scooping up shares. Being a penny stock we are easily manipulated. Add to this the risk in the biotech sector; it's easy to see how loose apples break away! Or those with stops in place.
It is merely the second of the seven deadly sins raising its ugly head... Greed.
Lastly and if I'm correct on this speculation I believe we'll pop shortly... we'll reverse split! If this is the case then I would call for insider trading/leak! And if so we have already corrected ourselves so expect a pop very shortly.
If you are long, as I am (2-5 year duration - initiated July 2012), then hold or acquire more! The fundamentals have not changed (to my knowledge). If you did your own DD then keep calm and believe in yourself. Don't be suckered into taking a hit in what is a enviable company to have found at such undervalued prices.