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$TPIV Seeking Alpha Transcript Q3- 2017
https://seekingalpha.com/article/4125314-tapimmunes-tpiv-ceo-peter-hoang-q3-2017-results-earnings-call-transcript?part=single
Dan O'Connor will have to earn those shares and is contingent upon shareholders vote at the next annual meeting which would be approx 10/25/18. Dan has one year to prove himself!
Mystery to me. However 51% ownership is now the total
Institutionals = 46%
Mutual Fds = 5%
Total = 51%
https://www.cnbc.com/quotes/?symbol=VCEL&tab=ownership
New totals are now
Institutionals = 46%
Mutual Fds = 5%
Total = 51%
IMO these details were very much part of the reasons why these new investors have taken +5% share ownership positions.
EP is very much needed to
(1) prevent toxic quantities of IL12
and
(2) cause an autologous reaction inside the tumor to make more IL12.
Not sure. I look at it daily as others do.
They are several years away and with only a Phase1. They will need a P2B and P3 which will take several years.
08/25/2016 Elite Laboratories Inc. New Jersey District Office Postmarketing Adverse Drug Experience (PADE) Not Issued *
Electroporation of the IL12 has distinct advantages vs other tech with IL12
hschlauch Do you have any thoughts or R&D history as to how $ONCS arrived at GENSIS EP is optimum at delivery of 400V/cm, 8 x 10ms pulses for the multicistronic DNA construct of proteins?
For those not familiar with $ONCS's new GENESIS™ delivery EP.
The OncoSec GENESIS™ research generator was developed specifically for gene electro-transfer. It features customizable electroporation parameters for construct-specific optimization of expression, and it is the only in vivo electroporation device enabled with TRACE™ Technology (Tissue-Based, Real-Time Adaptive Control Electroporation.)
TRACE™ technology incorporates an electrochemical tissue-sensing control system to automatically adjust pulse width and treatment duration in real time during the electroporation procedure. This feature enables tissue- and therapeutic-specific delivery optimization, maximizing uptake of the therapeutic while reducing unnecessary cell ablation or damage. In research models, GENESIS™ with TRACE™ has yielded higher and more consistent in vivo protein expression versus fixed-parameter electroporation, even in heterogeneous tissues.
Potential advantages of GENESIS™ with TRACE™ for use in murine models include robust and conformationally-native in vivo expression of difficult proteins, including GPCRs and receptors that function in multimeric form. Moreover, the consistent results obtained with these technologies in heterogeneous tissues support reliable intratumoral delivery of a wide variety of DNA-encodable therapeutics across multiple syngeneic, xenograft, and PDX models. Using these technologies, OncoSec has expressed more than fifty proteins in vivo, including multimers and structurally-complex fusion proteins, and no protein tested to date has failed to successfully express.
The OncoSec Technology Access Program makes OncoSec's electroporation technologies available to collaborators for preclinical research. Devices are available for intratumoral, intradermal, and intramuscular delivery.
Agree 100%. $ELTP is being both Naked and Covered shorted by certain groups . Pfizer not launching their approved Oxy/Nal drug is more of the same shenanigans happening against $ELTP
It is still there. However the FDA is issuing Nov 2017 Close Out Dates now for some of the other Pharmas.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/default.htm?Page=5
ELTP warning letter was 08/25/2016
Form 10-Q TAPIMMUNE INC. For: Sep 30
10K WIZARD 4:07 PM ET 11/14/2017
http://archive.fast-edgar.com/20171114/A7A2KQ2CZZ22QZZZ2HJG2ZZILDACCB22Z292
Filed on: November 14, 2017
Thxs. Another great find. Much appreciated.
No cannot see the images
ihub message for post 41000
"Message is private, ignored or otherwise unavailable"
I am not registered there. If you could, would you copy the warrant table and post it in ihub.
Waitforit53 would you please copy, paste, and post the warrant table
Thxs
Yes this is big. Obviously new CEO Peter Hoang rallying the troops.
NH $ELTP waiting for the FDA clearance approval letters for
(1) ADE SOPs site handling. ADE SOPs 2805 and 2810 have already been approved.
(2) ANDA Percocet
(3) ANDA Norco
$ELTP has done everything that the FDA requested.
FDA Monthly Approvals link working again.
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=reportsSearch.process
$ELTP complaint on Pfizer as Pfizer has not yet launched their FDA approved Oxycodone/Naltrexone ADF TROXYCA® ER which was approved Aug 2016
TapImmune Completes Patient Enrollment Ahead of Schedule in Phase 2 Cancer Vaccine Study for Treating Triple-Negative Breast Cancer
PR NEWSWIRE 6:30 AM ET 11/14/2017
Symbol Last Price Change
TPIV 2.7down 0 (0%)
QUOTES AS OF 04:00:00 PM ET 11/13/2017
JACKSONVILLE, Fla. , Nov. 14, 2017 /PRNewswire/ -- TapImmune Inc. , a leading clinical-stage immuno-oncology company with ongoing clinical trials in ovarian and breast cancer, today announced that it has enrolled the final patient in a randomized Phase 2 clinical study of its novel T-cell vaccine candidate TPIV200 for treating triple-negative breast cancer (TNBC). The comprehensive four-arm study is designed to help determine the optimal vaccine dose and regimen to maximize the immune response generated against the vaccine's molecular target, folate receptor-alpha (FRa), a cancer cell biomarker that is highly correlated with disease recurrence.
TapImmune Completes Patient Enrollment Ahead of Schedule in Phase 2 Cancer Vaccine Study for Treating Triple-Negative Breast Cancer
Dr. Richard Kenney, Head of Clinical Development for TapImmune(TPIV), stated, "We are pleased to complete enrollment in this study almost two months ahead of our original projections and want to thank our investigators and their teams for their diligence, as well as their patients for contributing to the development of this vaccine. Our Phase 2 trial focuses on women who have completed initial surgery and radiation/chemotherapy for TNBC at least 60 days prior to randomization. We believe vaccination with TPIV200 during this important window may potentially delay or prevent cancer recurrence by generating robust T-cell immunity against tumor cells. Evaluating multiple vaccine dosing strategies in this Phase 2 trial may enhance our ability to generate optimal immune responses and prevent disease recurrence in future pivotal clinical studies."
TapImmune (TPIV) and its clinical partners are evaluating TPIV200 in multiple ongoing Phase 2 trials for treating ovarian and breast cancers, including a 280-patient efficacy trial sponsored by the Mayo Clinic that is randomized, double-blind, and placebo-controlled to evaluate disease-free survival in women with advanced TNBC. This larger clinical study to evaluate efficacy is fully funded by a $13.3 million grant from the U.S. Department of Defense and patient dosing is expected to begin by year end 2017.
Peter Hoang , President and CEO of TapImmune(TPIV), stated, "Triple-negative breast cancer is a difficult-to-treat condition, but one where patients may stand to benefit significantly from immunotherapies that are effective at continually fighting off disease progression long after initial cancer therapy. As a multi-peptide therapeutic vaccine, TPIV200 is designed to do just that. I also want to congratulate our clinical team and thank them for their hard work in getting us to this milestone ahead of schedule. We look forward to reporting interim immunogenicity results in the first half of 2018 and continuing the booster phase of this Phase 2 dosing study, as well as to Mayo Clinic initiating the long-term Phase 2 efficacy study in TNBC."
About TPIV200
TPIV200 is a novel peptide-based cancer vaccine that has been shown to induce a robust and long-lasting "memory" T-cell immune responses directed against folate receptor alpha (FRa), a molecule that is overexpressed on the surface of the vast majority of TNBC cancer cells and is associated with cancer recurrence. As an off-the-shelf vaccine consisting of several carefully chosen FRa peptides, TPIV200 is uniquely able to stimulate both "helper" T cells and "killer" T cells to target tumor cells, and the vaccine peptides are predicted to cover greater than 85% of human genotypes worldwide.
About the Phase 2 Trial
The randomized, multi-center study enrolled over 80 women with stage I(T1c)-III triple-negative breast cancer (TNBC) who have completed initial surgery and radiation/chemotherapy, and who have not yet had a cancer recurrence. The four-arm study randomized patients to receive six monthly injections with a high dose or a low dose of TPIV 200, with or without a single treatment of cyclophosphamide prior to vaccination. Patients will continue to receive a booster vaccine every six months while they remain progression-free. The primary endpoint of the Phase 2 study is the immune response against the vaccine target, folate receptor-alpha (FRa), as measured by the presence of anti-FRa T cells.
About TapImmune Inc.(TPIV)
TapImmune Inc. (TPIV) is a leader in the development of novel immunotherapies for cancer, with multiple Phase 2 and Phase 1b/2 clinical studies currently ongoing for the treatment of ovarian and breast cancer. The company's peptide- or nucleic acid-based immunotherapeutic products comprise multiple naturally processed epitopes (NPEs) designed to comprehensively stimulate a patient's killer T cells and helper T cells, and to restore or further augment antigen presentation by using proprietary nucleic acid-based expression systems. This unique approach can produce off-the-shelf T-cell vaccine candidates that elicit a broad-based T-cell response and can be given without respect to HLA type. The company's technologies may be used as stand-alone medications or in combination with other treatment modalities.
For additional information, please call toll free at (904) 862-6490 EXT. 102 or visit: https://tapimmune.com/
To receive future press releases via email, please visit:
https://tapimmune.com/investors/email-alerts/
BP = Big Pharma. Such as Merck, Bristol-Myers Squibb, Roche, AstraZeneca etc. These specific BPs already have FDA approved drugs for anti PD-1/PD-L1 Commercial Treatments.
In Partnership negotiations with BP, it is highly essential to always have strong COH. In this way, the BP knows that you cannot be intimidated and panicked into taking a deal that mostly benefits the BP.
The BPs will be lined up to try and get the Partnership deal with $ONCS. $ONCS can now be very selective in choosing their BP Partner that benefits $ONCS shareholders the best.
Understandable as R&D, with future value. However at this point as Dan O'Connor knows $ONCS needs to drive the Partnership discussion with BPs in order to generate Commercial revenues.
Deal "with the one in the hand and not the two in the bush".
With Commercial revenues flowing in, $ONCS will have unlimited funds for R&D galore.
You can be assured that the two Dhillons, founders of $ONCS, Avtar and Punit , have a tight leash on Dan.
Dan O'Connor smart negotiations as ADXS CEO in partnership with Amgen strategy in play here for $ONCS Partnership?
http://www.amgen.com/media/news-releases/2016/08/amgen-and-advaxis-enter-global-cancer-immunotherapies-collaboration/
PISCES 48 person at $40,000 per person IMO, call it $2 mil. Something more going on as to why $ONCS raising more cash IMO. $ONCS negotiating Partnership with hi cash on hand for leverage?
Form 8-K ONCOSEC MEDICAL Inc For: Nov 13
10K WIZARD 3:17 PM ET 11/13/2017
http://archive.fast-edgar.com/20171113/AC22GG2CZC2R8ZU2222A2ZX28QJG7Z22Q292
Filed on: November 13, 2017
$ONCS looking to make new 52 week HI in the +$3s?
Yes. Everybody is looking for new 52 week HIs
$ONCS new 52 week HI $$2.93
$ELTP will receive the hard copy registered FDA approval letter first
This is the link that use to work.
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
I am thinking that also.
sharkey1 Do you have the FDA link for monthly approvals?
Something going on this morning. IMO when $ONCS partners, this valuable new research could be part of a partnership package.
$ONCS new 52 week Hi, $2.65
You mean in regards to $ONCS SITC presentation?
https://ir.oncosec.com/press-releases/detail/1926/oncosec-announces-preclinical-data-demonstrating-multi-gene