So they Chitcanned the Admin Offices. This mean 2 Cent Eddie is next???
Dynavax AdCom was cancelled to allow time for the FDA to review and resolve several outstanding issues. “The November 16, 2016 Vaccines and Related Biological Products Advisory Committee meeting, to discuss and make recommendations on the safety and efficacy of a Hepatitis B Vaccine manufactured by Dynavax, has been cancelled to allow time for the FDA to review and resolve several outstanding issues. The agency intends to continue evaluating and will schedule an Advisory Committee meeting in the future, as needed.” https://www.fda.gov/AdvisoryCommittees/Calendar/ucm518600.htm
CANCELLED: November 16, 2016 Meeting of the Vaccines and Related Biological Products Advisory Committee
The meeting of the Vaccines and Related Biological Products Advisory Committee scheduled for November 16, 2016, is cancelled. This meeting was announced in the Federal Register of Tuesday, August 30, 2016 (Vol. 81, No. 168, FR pages 59634, 59635).
approval any day now is what i'm being told from some people in the street,i still don't expect a big pop in the stock though
Not sure why all the Aug Hub bub
Meeting Scheduled for July 28, 2017 BERKELEY, CA -- (Marketwired) -- 04/03/17 -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that the U.S. Food and Drug Administration (FDA) has informed the company that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will review HEPLISAV-B™ [Hepatitis B Vaccine, Recombinant (Adjuvanted)] at its meeting scheduled for July 28, 2017. The scheduled VRBPAC meeting is close to the HEPLISAV-B Prescription Drug User Fee Act (PDUFA) date of August 10, 2017 solely as a function of meeting logistics. The PDUFA date remains unchanged. The FDA will communicate specific questions for the VRBPAC to address closer to the meeting date, and will post a draft agenda and draft questions on its website 48 hours prior to the meeting. HEPLISAV-B is the company's vaccine candidate for immunization against hepatitis B infection in adults ages 18 years of age and older.
Wondered why all those Mayflower moving Trucks were on Google Earth at DVAX location.
Exactly how much dilution is being voted on 1.6 million and or 69.5 million?
Guessing they've run out of any buyers at this level and are taking it down to next lower level to sell a bunch more ATM shares
Tomorrow after close, we will see if there is anything new on SD-101 trials.
See why biotech/pharma shareholders are adding this breakthrough wound care to their portfolio. BioLargo recent 10Q states: • Advanced Wound Care products are ready, all studies successfully completed, and they expect to file a 510K with FDA in less than 90 days • Woundcare market is over $6 Billion with high growth rate • Tanya Rhodes, ex VP of Smith & Nephew Wound Care Product Development is leading the BLGO/Clyra Medical 510K filing • BLGO/Clyra Medical Wound Care Products promote healing substantially better than competing products, fight infection better than competing products, are effective against resistant microbials, and are low cost • Sales could commence late 2017 • Sales and or licensing agreement/s could be very significant and fast • Company is now commercializing several other disruptive products in large markets
Maybe someone can explain how the recent SD101 study says 66% ORR but this previous one in March says 86%?
In patients naïve to anti-PD-1 treatment, responses were observed in six out of seven patients, for an Overall Response Rate (ORR) of 86%. This includes two (29%) complete responses (CR) and four (57%) partial responses (PR). Target tumor shrinkage was observed in all 7 evaluable patients. In 10 patients with progressive disease who initiated KEYTRUDA anti-PD-1 monotherapy prior to enrollment, one PR was observed and five patients had stable disease (SD) while receiving KEYTRUDA and SD-101, with four of the 10 patients experiencing target tumor shrinkage. These data are being presented by Robert Janssen, M.D., chief medical officer for Dynavax, in an oral presentation at the International Congress on Targeted Anticancer Therapies which begins today in Paris, France.
It's going to get approved. This same thing has happened many times before with other drugs. There is no real reason not to approve it.
X axis : Stocks Price Correlation Coefficient Y axis : Quantity of stocks Sep-2016 1,000 Day Parameter 2,830 NASDAQ Stocks Price Analysis This stock mode of correlation coefficient is -0.3 In other words, the correlation coefficient of the other stoc
If Heplisav is approved, I believe GILD is already prepared to buyout DVAX. Heplisav would fit well into their Hep-B portfolio while SD-101 has progressed and shown sufficient significant potential to fit into their desire for developing their own immunoncology pipeline. The rest of DVAX's pipeline is gravy. Considering DVAX's micro-capitalization and clean balance sheet, this company looks like a compelling acquisition. GILD could buy this company with their pocket change while reaping potentially substantial accretive benefit and regaining confidence in their own investor base. GILD needs DVAX as much as DVAX needs GILD. They're stronger together at a time when they're both desperate to be stronger.
Keytruda alone CR was 6% and PR 27% with 2 deaths in metatastic melanoma per kettuda com website. This DID NOT have SD-101 and is only Keytruda. This may give you some baseline comparison. 277 patients in trial data Trial KEYNOTE-006
PDUFA on 8/10/17 has been removed on FDA calendar, but has a note on the 7/28/17 meeting that PDUFA is 8/10/17. Any thought's why the removed the entry on 8/10/17 FDA calendar?
Primary results from a randomized (1:1), open-label phase II study of talimogene laherparepvec (T) and ipilimumab (I) vs I alone in unresected stage IIIB- IV melanoma. | 2017 ASCO Annual Meeting Abstracts
9509 Primary results from a randomized (1:1), open-label phase II study of talimogene laherparepvec (T) and ipilimumab (I) vs I alone in unresected stage IIIB- IV melanoma. Jason Alan Chesney, Igor Puzanov, Merrick I. Ross, Frances A. Collichio, Moha