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).
Exactly how much dilution is being voted on 1.6 million and or 69.5 million?
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.
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.
Soooo ASCO Abstracts post at 5PM today ....... Someone one going out on a limb with their projection
SEE post by CDS from 7 days ago (with link) -impressive article about SD-101 & Keytruda in treating mestatic melanoma:
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
hope you are in; tomorrow; big Merck Ketruda news....
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(AXSM) Market Cap $92 M/Cash $55 M / 5x BIG Phase 3 programs in various indications targeting large Markets with first results in Q3 2017 =20 BAGGER ..FANTASTIC OPPORTUNITY !
Undiscovered and massive undervalued Biotech Stock with lots of Big News on the way.This Stock is brutally undervalued with a Market cap of just $92 million and $55 million in cash .Founder and Ceo is the larget shareholder holding over 7 million shares (30%) more than 50% of O/S is owned by Insider and Institutions which is a great sign .
This undiscovered stock could be the next 10 bagger gem if just one of their 5 ongoing Phase 3 programs is successful .GL
Market-Cap: $92 Million Cash: $55 Million(cash runway into the first quarter of 2019.) Price:$4.10
Shares Out: 23.5 Million
Anticipated Near-Term Clinical Milestones
Clinical Trial Initiations: -- Phase 2/3 clinical trial of AXS-05 in AD agitation (2Q 2017)
Clinical Trial Readouts:
-- Phase 3 COAST-1 trial of AXS-02 in knee OA associated with BMLs, interim analysis (3Q 2017)
-- Phase 3 CREATE-1 trial of AXS-02 in CRPS, interim efficacy analysis (4Q 2017)
-- Phase 3 STRIDE-1 trial of AXS-05 in TRD, top-line data (1Q 2018)
ClinicalTrials.gov Identifier: NCT02898662 First received: August 16, 2016 Last updated: April 11, 2017 Last verified: April 2017
Ph2a study planned to be run at approximately 16-18 sites in 4 EU countries (Denmark, Hungary, Poland and Sweden) enrolling approximately 170 patients to ensure 70 randomized patients with eosinophilic, moderate to severe asthma. The patients will receive 13 once weekly inhaled doses of the study drug. Treatment is initiated on top of their ICS/LABA controller medication, which is then tapered down and withdrawn during a period of 3 weeks and during the last 3 weeks of treatment the study drug is given as monotherapy. SABA is used as reliever medication during the whole study period. Primary endpoint is Loss of asthma control. When the endpoint is met, patients will resume their ICS/LABA, will be followed for an additional 4 weeks and will thereafter discontinue the study. https://clinicaltrials.gov/ct2/show/NCT02898662
AZD1419 Ph2a Study - Full Text View - ClinicalTrials.gov
Phase 1b/2, open label, multicenter, study of intratumoral SD-101 in combination with pembrolizumab in anti-PD1 naïve & experienced metastatic melanoma patients. | 2017 ASCO Annual Meeting Abstracts
9550 Phase 1b/2, open label, multicenter, study of intratumoral SD-101 in combination with pembrolizumab in anti-PD1 naïve & experienced metastatic melanoma patients. Abraham C.F. Leung, Shivaani Kummar, Sanjiv S. Agarwala, John J. Nemunaitis, Rene G