Tuesday, August 25, 2015 12:39:30 PM
Seen so many posters have replied to your endless FUD, I am going to take this exception to reply to your post (no further replies shall be expected):
If it is due to safety issue, the company would not only stop screening patients, it would have to stop recruiting and treating any patients (existing and potential). See example below:
" Oncothyreon announces temporary suspension of Stimuvax clinical trials by Merck Serono
SEATTLE, March 23, 2010 /PRNewswire via COMTEX News Network/ -- ONCOTHYREON TO HOLD TELECONFERENCE AT 5:00 PM EDT
Oncothyreon Inc. (Nasdaq: ONTY) today announced that Merck Serono, a division of Merck KGaA of Darmstadt, Germany, and its U.S. affiliate, EMD Serono, Inc., have temporarily suspended the worldwide clinical development program for Stimuvax(R) (BLP25 liposomal vaccine). The suspension is the result of a suspected unexpected serious adverse reaction in a patient with multiple myeloma participating in an exploratory clinical trial. This decision was taken in alignment with the U.S. Food and Drug Administration's (FDA) clinical hold placed on the Investigational New Drug (IND) application for Stimuvax.
The suspension affects the Phase 3 clinical program for Stimuvax, including the START and INSPIRE trials in non-small cell lung cancer (NSCLC) and the STRIDE trial in breast cancer. Further recruitment of patients into all trials actively recruiting patients and ongoing treatment with Stimuvax in these trials are suspended.
"Patient safety is of paramount importance to Merck Serono and to Oncothyreon," said Robert L. Kirkman, M.D., President and CEO of Oncothyreon. "We understand that Merck Serono is working closely with the FDA, other regulatory agencies and the patient's physicians to evaluate the implications of this adverse reaction and to determine an appropriate course of action."
The exploratory trial in multiple myeloma is designed to investigate the mechanism of action of Stimuvax and the effect of cyclophosphamide on regulatory T cells, which may affect the response to the therapeutic vaccine. The adverse event occurred in a patient receiving a more intensive regimen of low-dose cyclophosphamide than is utilized in the Phase 3 program. The patient developed an encephalitis, or inflammation of the brain. No other events of this kind have been reported in other trials of Stimuvax to date.
Conference Call Information
Oncothyreon will host a conference call and webcast today at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time. To participate in the call by telephone, please dial 877-280-7291 (United States) or 707-287-9361 (International). In addition, the call is being webcast live and can be accessed on the "Events" page of the "News & Events" section of the Company's Web site at www.oncothyreon.com. An archive of the webcast will be available after completion of the discussion and will be posted on the Oncothyreon website.
About Stimuvax
Merck KGaA has an exclusive world-wide license from Oncothyreon for Stimuvax. Merck KGaA is investigating the use of Stimuvax(R) (BLP25 liposome vaccine) in the treatment of NSCLC. The vaccine was granted fast-track status in September 2004 by the FDA. Stimuvax is being developed in Europe by Merck KGaA and in the United States by its affiliate, EMD Serono Inc.
START is a multi-center, randomized, double-blind, placebo-controlled Phase 3 study that will evaluate patients with documented unresectable stage IIIA or IIIB NSCLC who have had a response or stable disease after at least two cycles of platinum-based chemo-radiotherapy. The study will involve more than 1,300 patients in approximately 30 countries.
The INSPIRE study is a multi-national, Phase 3, double-blind, placebo-controlled, randomized clinical trial designed to evaluate the efficacy, safety and tolerability of Stimuvax in subjects suffering from unresectable, stage III NSCLC and demonstrating either stable disease or objective response following primary chemo-radiotherapy. The study will enroll approximately 420 unresectable, stage III NSCLC patients across China, Hong Kong, Korea, Singapore and Taiwan.
STRIDE is a randomized, double-blind, controlled, multi-center Phase III study designed to determine if Stimuvax(R) can extend progression free survival in patients treated with hormonal therapy who have inoperable, locally advanced, recurrent or metastatic breast cancer. Overall survival, quality of life, tumor response and safety will also be assessed in this study."
The link is here: http://ir.oncothyreon.com/releasedetail.cfm?releaseid=453976
I keep adding shares and options since this drop. Today I also add 20 2017 target $10 call contracts at $2.15 a piece.
I will continually urge people not to reply to your posts, since you are a person proven not trustworthy (moderator it's my genuine opinion, please not think it is a personal attack and name calling. Thank you).
Too busy, not time to post further, and life is beautiful, not intend to waste my time in thing like this.
Recent NWBO News
- Biophma Announces Exclusive In License for Dendritic Cell Technology, Sending Shares Higher • AllPennyStocks.com • 06/17/2024 04:40:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/04/2024 09:11:16 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 06/03/2024 09:22:55 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 05/22/2024 08:13:36 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/10/2024 09:04:57 PM
- Form NT 10-K - Notification of inability to timely file Form 10-K 405, 10-K, 10-KSB 405, 10-KSB, 10-KT, or 10-KT405 • Edgar (US Regulatory) • 03/01/2024 10:04:38 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/02/2023 01:31:35 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/16/2023 10:11:54 PM
- Epazz, Inc. (OTC Pink: EPAZ) ZenaDrone Demonstration to Defense Departments of UAE and Saudi Arabia • InvestorsHub NewsWire • 11/15/2023 12:19:31 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/09/2023 09:30:39 PM
- Epazz, Inc. (OTC Pink: EPAZ) US Navy Collaboration ZenaDrone 1000 • InvestorsHub NewsWire • 11/09/2023 01:00:34 PM
- Epazz, Inc. (OTC Pink: EPAZ) US Navy Collaboration ZenaDrone 1000 Extreme Weather Demo • InvestorsHub NewsWire • 11/07/2023 12:29:43 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/09/2023 08:36:14 PM
Glidelogic Corp. Becomes TikTok Shop Partner, Opening a New Chapter in E-commerce Services • GDLG • Jul 5, 2024 7:09 AM
Freedom Holdings Corporate Update; Announces Management Has Signed Letter of Intent • FHLD • Jul 3, 2024 9:00 AM
EWRC's 21 Moves Gaming Studios Moves to SONY Pictures Studios and Green Lights Development of a Third Upcoming Game • EWRC • Jul 2, 2024 8:00 AM
BNCM and DELEX Healthcare Group Announce Strategic Merger to Drive Expansion and Growth • BNCM • Jul 2, 2024 7:19 AM
NUBURU Announces Upcoming TV Interview Featuring CEO Brian Knaley on Fox Business, Bloomberg TV, and Newsmax TV as Sponsored Programming • BURU • Jul 1, 2024 1:57 PM
Mass Megawatts Announces $220,500 Debt Cancellation Agreement to Improve Financing and Sales of a New Product to be Announced on July 11 • MMMW • Jun 28, 2024 7:30 AM