Inovio Pharmaceuticals Inc (INO)

[Lakers_w]

mRNA-P1PR-took-4-mos 7/14-11/12. Ino-submitted 7/31, should-be-published-12/2-NEJM
Moderna Announces Publication in The New England Journal of Medicine of Interim Results From Phase 1 Study of Its mRNA Vaccine Against COVID-19 (mRNA-1273)

July 14, 2020 at 5:14 PM EDT
https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-publication-new-england-journal-medicine

An mRNA Vaccine against SARS-CoV-2 — Preliminary Report
List of authors.
Lisa A. Jackson, M.D., M.P.H., Evan J. Anderson, M.D., Nadine G. Rouphael, M.D., Paul C. Roberts, Ph.D., et al., for the mRNA-1273 Study Group*

November 12, 2020
N Engl J Med 2020; 383:1920-1931
https://www.nejm.org/doi/full/10.1056/nejmoa2022483

P1PR will likely be published online in NEJM Wed, 12/2/20. Now that P2-starts, the reviewers have no reason not to accept and publish.

P2 funding for 400 ppl, $50K/per, $20M must have been disbursed for P2 to start. Considered a material event, It’d show up immediately in 8-K and eventually in 10-K soon!!

P3:6187 ppl, $309.35M. Total $330M could be announced in whole (likely) or in part as P2/3 are combined in a single FDA ClinicalTrials ID. CEO Joseph Kim might have waited for P3 hold lifted after 3PSP questions are satisfactorily answered to announce $330M.

Inovio responds to questions about experimental Covid-19 vaccine, awaits ruling on late-stage trial
John George, Senior Reporter
Nov 2, 2020, 4:33pm EST
Inovio said Monday it has responded to the Food and Drug Administration's questions about its experimental Covid-19 vaccine and the vaccine's delivery device.

The federal agency now has 30 days to respond, from the date it received Inovio's answers, and let the Plymouth Meeting biotech company know whether it can begin late-stage testing of its INO-4800 vaccine candidate.

Inovio declined to say exactly when it submitted its response.

"We look forward to hearing back from the FDA in November and continue to prepare for a planned phase-II/III trial of INO-4800," Inovio said in a statement provided to the Philadelphia Business Journal. "As a reminder, the partial clinical hold by the FDA is not due to the occurrence of any adverse events related to Inovio’s ongoing expanded phase-I study of INO-4800, which has continued, and does not impact the advancement of Inovio's other product candidates in development.”

On Sept. 28, Inovio (NASDAQ: INO) disclosed its planned phase-II/III clinical trial for INO-4800 was going to be delayed because the FDA had raised additional questions about the experimental vaccine and Inovio's Cellectra 2000 device used to deliver the vaccine.

Inovio, one of more than 125 life sciences companies around the world working on a potential Covid-19 vaccine, had hoped to initiate the late-stage clinical trial by the end of September.

Big Pharma companies AstraZeneca, Pfizer and Johnson & Johnson, along with small biopharm companies Moderna and Novavax, have advanced vaccine candidates into late-stage clinical testing.

Both AstraZeneca (NYSE: AZN) and Johnson & Johnson (NYSE: JNJ) had to temporarily halt their late-stage studies because of unexplained illnesses of study participants. Regulators and independent committees overseeing the studies have since determined both trials can safely resume.

Inovio's INO-4800 vaccine candidate is a DNA-based vaccine the company developed in a partnership with the Wistar Institute in Philadelphia and others. The vaccine's proprietary Cellectra delivery device, developed by Inovio, delivers the vaccine into the patient’s skin using an electrical pulse in a process that takes only a few seconds.

The hand-held Cellectra device administers a brief electrical pulse to reversibly open small pores in skin-area cells. Once inside the cell, the vaccine's DNA plasmids instruct the cell to produce the targeted antigen against the virus.
https://www.google.com/amp/s/www.bizjournals.com/philadelphia/news/2020/11/02/inovio-covid-19-vaccine-candidate-fda-study-trial.amp.html