Pharmacyclics (PCYC) already has a treatment for CLL, ibrutinib, which was recently given accelerated approval by the FDA. TGTX is using its treatment along with ibrutinib to improve patient response above and beyond what ibrutinib itself has shown in CLL patients. TGTX has been on a HUGE run up since presenting this news (including at ASCO) just a couple of weeks ago. TGTX's most advanced clinical candidate is in Phase II, whereas NWBO obviously has its Phase III going solidly with full-enrollment not too far off. Yet, TGTX (up 10.44% just today on no new news, interestingly) has a market cap now near 300 million--close to NWBO. From a pipeline perspective, and from a financial perspective, NWBO should be a MUCH bigger company already. The value of potential revenue for treating ALL inoperable solid tumors is much higher (obviously) than that for CLL. There is absolutely no logical reason for NWBO not having a market cap 4 or 5 times greater than TGTX, if you ask me. It's only a matter of time before this changes. Getting news on DC-vax L and the DMC's view on efficacy should also serve to be a huge catalyst for NWBO going forward. There are a number of small cap biotechs that appear way Overvalued compared to NWBO. Merck's offer to buy out Idenix for almost $3.9 billion just yesterday comes to mind. Yes, hep C is a big market, but their most advanced trial was also only Phase II, and hep C is still a small market compared to ALL solid operable and inoperable tumors! Hence, the mother of all asymmetrical biotech investment opportunities has emerged with NWBO, imho.
Another AF and Jim's cheated #$%$, but both of these clowns changed now their opinion in their new updates with Price Target above $10. Inviting Linda for Dinner which Linda refused in Public.
Battle of the Short Sellers against the Longs
Since the beginning of the year, NWBO has been the subject of significant shorting activity. The battle of the shorts against the longs can be seen by looking at the rise in stock sold short that is provided by NASDAQ and the price action. On December 31, 2013 there were 3.4 million shares that were short and the price closed at $3.77. By February 28, 2014 the short interest was 4.6 million and the price closed at $7.09. By May 30, 2014 the short interest 6.7 million and the stock closed at $5.98. The closing price yesterday, June 11, was $6.41.
The shorts seem to have had a significant impact on the stock since March. The stock price is flat despite the very positive announcement of the approval of DCVax-L in Germany for the treatment of all gliomas (brain tumor) under the German hospital exemption early access program. This approval for five years goes far beyond the disease target for the phase 3 trial that is glioblastoma multiforme, the most aggressive form of brain cancer. DCVax-L is also eligible for reimbursement in Germany comparable to drugs that have gone through the traditional approval process. This was the first such approval for any systemic drug under this program since it was implemented in 2011. This is a really big deal. In addition to the German approval of DCVax-L, NWBO has released some very interesting early data on DCVax Direct as discussed earlier.
The bears have attacked NWBO on its decision to give updates on its phase 1/2 trial of DCVax Direct in inoperable solid tumors as the trial progresses. I have seen short sellers try to negate the encouraging data that has been shown with specious arguments. The most laughable argument was that the tumor necrosis that has been seen was the result of sticking the syringe carrying DCVax Direct into the tumor mass.
The bears have also implied that releasing data as the trial progresses that NWBO is somehow acting unethically or doing something wrong. T
Is the issuer subject to both Exchange Act and Securities Act liability?
Yes. The issuer is subject to Exchange Act liability, and under certain circumstances also liability under the Securities Act.
The content of the information and the disclosures made by the issuer in the periodic and current reports may be subject to liability under Sections 10, 13(a), 15(d) and 18 and Rule 10b-5 of the Exchange Act.
AF Calling Linda for a Dinner and she refused.
Independent Data Monitoring Committee recommends First Interim Analysis Of NW Bio's Phase III GBM Trial ...
EARLY POSITIVE RESPONSES SEEN IN OVER 50% OF DCVAX®-DIRECT ... NW Bio Receives Recommendation To Continue With Phase III GBM Brain Cancer ... I believe the IDMC gives the information to the company directly -
Raise your hand if you took seriously my $NWBO tweet from earlier today. OK, now all of you stand in a corner, facing the wall.
Pertaining to efficacy, the study measures regression of disease from late-stage cervical pre-cancer (CIN 2/3) to early stage pre-cancer (CIN 1) or elimination of disease. The study is 80% powered to achieve a 52% response rate in vaccinated subjects compared to a hypothetical 25% in the control group. The 25% figure is based on natural regression response rates that have ranged from 4% - 40% in other studies.
CEO Joseph Kim will undoubtedly join Northwest Biotherapeutics (NWBO +5.8%) Chief Linda Powers in declining a dinner invitation with Mr. Feuerstein.
His remarks was more jealous then any material facts which he can bring out to the investors out from ASCO when NWBO set up the biggest booth this year at ASCO.
Brain cancer vaccine
One of the most exciting breakthroughs in brain tumor treatment is a vaccine made from a patient’s own tumor cells. Vaccines have been the focus of research for decades, as they offer a less-toxic approach than traditional chemotherapy. However, most vaccines to date have fallen short—delivering positive results for a small group of patients, but proving less effective when tested across multiple sites.
Now, with phase I trials showing very positive results for a new GBM vaccine, a phase II, randomized, multicenter study is underway. IU Health is the only center in the region offering access to the DCVax-Brain trial for newly diagnosed GBM.
“What’s exciting to me is that we are using the patient’s own immune system to fight the brain tumor,” Dr. Miller said. “The vaccine is created by taking a patient’s tumor proteins and combining them in the laboratory with the patient’s immune cells to ‘activate’ them. When those activated immune cells are re-injected, they help attack the residual brain tumor cells. It’s a highly personalized treatment.”
Basic Trial Information
Phase Type Status Age Sponsor Protocol IDs
Phase II, Phase I Treatment Active 18 to 75 Pharmaceutical / Industry NWBio 050012
The study comprises a Phase I component during which the optimal dose of DCVax-Direct for the treatment of solid tissue tumors will be identified, followed by a Phase II component to determine if the injection of DCVax-Direct into selected solid tissue tumors has the ability to reduce tumor growth.
Orlando M.D. Anderson Cancer Center at Orlando
Mollie Geismer, RN, PhD, CCRP
Omar Kayaleh, MD Principal Investigator
M. D. Anderson Cancer Center at University of Texas
Babita Saigal, MD Ph: 713-745-8618
Patient Access Center Ph: 713-792-1160
Vivek Subbiah, MD Principal Investigator
Breakthroughs in Brain Tumor Treatment | IU Health
In fact, of the estimated 22,000 new cases of primary brain cancer diagnosed ... IU Health is the only center in the region offering access to the DCVax-Brain trial ...German Approval for Early Access with DCVax-L(N...