CYBR will be $100+ by spring
this will be $100+ spring 2015.
DCVax-L could in very short order replace Avastin for rGBM after potentially becoming SOC along with temozolomide for ND-GBM (Temodar being generic also assists in subsidized costs). Data on some 276 patients would dwarf the open-label patient population with rGBM being treated with Rindo. Not to mention open-label data that will have accrued on rGBM patients treated in German via Hospital Exemption
Given the choice to subsidize one or the other (insurance carries will not bear the burden of subsidizing two novel therapies for the same indication), insurers and doctors would certainly choose DCVax-L over Rindo. Also, should data indeed show such an improvement over SOC, the Ph III DCVax-L trial would be halted mid-2015, and a BLA filed. CLDX has to wait until at least early 2017 to learn Rindo's fate. DCVax-L would have been approved long before CLDX receives top-line data on their Ph III trial (let alone begin the process of filing for approval, a process that can take upwards of a year).
See SA article
from a drug that caused birth defects. He was up against it and prevailed BIG TIME. Taking Celgene from nothing. This imo could prove even bigger. Shorts tried to bury Celgene early too !
When considering the above, NWBO has the potential to fare as well or better than JAZZ, ONYX, PCYC, ICPT and a host of other small biotech companies that went on to attain much higher market caps or were bought out. The greater risk in this situation may be missing another one in the making.
These companies also had experienced negative sentiment and high short interest at times before approval, but afterwards many looked and said, "How did I miss that?" Hind sight is always 20/20. Even not getting AAPL at a good price is a regret many investors carry.
Apparently DCVax-Direct is "able to overcome tumor immune suppression, both locally and systemically." It will be interesting to examine the content of the soon to be released study data proving this point.
It is unknown whether the study data will be on several specific patients that have undergone the entire course of therapy (6 injections over 8 months) or available whole group data based on those that have received at least 5 of 6 injections (representing a minimum of 4 months on therapy). But whatever the basis for the paper, it has the backing of three world renowned leading medical institutions, and the data presented at the conference will later appear in a peer reviewed medical journal.
The 11 study authors and their affiliations are:
Vivek Subbiah, MD, Assistant Professor, Department of Investigational Cancer Therapeutics, University of Texas M.D. Anderson Cancer Center Houston; Omar Kayaleh, MD; Orlando Health, Ravi Murthy, MD, MD Anderson Cancer Center, Texas; David Hong, MD, U. T. M. D. Anderson Cancer Center; Siqing #$%$, MD U. T. M. D. Anderson Cancer Center; Aung Naing, MD U. T. M. D. Anderson Cancer Center, Texas; Anthony Conley, MD, U. T. M. D. Anderson Cancer Center; Chitra Hosing, MD, U. T. M. D. Anderson Cancer Center; Indreshpal Kaur, MD, U. T. M. D. Anderson Cancer Center; Robert Prins, PhD, ULCA; #$%$nda Meric-Bernstam, MD, U. T. M. D. Anderson Cancer Center; Marnix Bosch, PhD, Northwest Biotherapeutics, Maryland.
NWBO will be presenting during the poster sessions on Nov. 7th, and the title of that poster is:
"Activated autologous dendritic cells injected intratumorally are able to overcome local and systemic immune suppression imposed by the tumor and its microenvironment."
As you can see, according to this modeling the DCVax-L group appears to be significantly outperforming placebo. It is difficult to find another way in which they reached only 66 PFS events with those two known enrollment points. I do not see another way possible. DCVax-L is likely showing exceptional efficacy
Thus here we have two highly regarded regulatory bodies (MHRA and PEI) that have examined all available DCVax-L clinical data to date, and have both unanimously given the therapy an early nod of approval based on efficacy and safety of therapy, seeking to have their citizens treated with the promising new medicine ASAP, and are even willing to subsidize this therapy while it is still in clinical development (in the case of Hospital Exemption). It's hard to overstate such outstanding and literally unprecedented validation
Of course that would refer to a major advantage over Standard of Care (SOC). This represents a significant validation for the DCVax technology, and in MHRA's opinion (the equivalent to FDA in the US) after rigorous examination, "DCVax-L is likely to offer a major advantage over SOC." The next step will be almost certain acceptance into UK's "Early Access to Medicines Scheme," whereby UK citizens may be granted access to DCVax-L outside of the ongoing Ph III clinical trial.
Also, through another program known as Hospital Exemption, the PEI (equivalent to FDA in Germany) has granted early access approval to DCVax-L in February to be used to treat any German citizen with any stage glioma, both newly diagnosed and recurrent (over 12,000 cases per year in Germany alone). This even though the Ph III trial is being tested in newly diagnosed GBM (ND-GBM) patients only.
very low float will give volatility but also a higher support level has been established with todays profit taking. Buy any dips.