Pregnancy Release Form Ten New Thoughts About Pregnancy Release Form That Will Turn Your World Upside Down
– Assigns PDUFA Ambition Date of May 25, 2020 –
SAN DIEGO, Dec. 18, 2019 /PRNewswire/ — Evofem Biosciences, Inc. (NASDAQ: EVFM), a clinical-stage biopharmaceutical company, today appear that the U.S. Food and Drug Administration (FDA) accustomed cancellation of the New Drug Application (NDA) resubmission for Amphora®, a Multipurpose Vaginal pH Regulator (MVP-R™), for the blockage of pregnancy. Deemed a Class 2 resubmission by the FDA, the bureau has assigned a six-month analysis aeon and a Decree Drug User Fee Act (PDUFA) ambition date of May 25, 2020.
(PRNewsfoto/Evofem Biosciences, Inc.)
“Today’s accepting brings us one footfall afterpiece to carrying the aboriginal accurate contraceptive addition in decades,” said Saundra Pelletier, Evofem Biosciences’ Chief Executive Officer. “We attending advanced to continuing to assignment carefully with the FDA during the analysis action and to the abeyant to action women a new, non-hormonal decree contraceptive advantage that puts them in ascendancy of their animal health.”
The Amphora NDA resubmission includes abounding after-effects from the Phase 3 AMPOWER study, a acknowledging single-arm, open-label Phase 3 balloon that evaluated the adeptness and assurance of Amphora in about 1,400 advantageous women ages 18 to 35 years.
The Aggregation is additionally evaluating the abeyant use of Amphora for the blockage of urogenital chlamydia and gonorrhea in women. Top-line after-effects from the Phase 2b AMPREVENCE trial, appear in December 2019, approved that the abstraction met both its primary and accessory endpoints, with a 50% about accident abridgement in chlamydia infection and a 78% about accident abridgement in gonorrhea infection compared to placebo.
About AmphoraAmphora® (L-lactic acid, citric acerbic and potassium bitartrate) is an investigational Multipurpose Vaginal pH Regulator (MVP-R™) advised to adapt vaginal pH aural the accustomed ambit of 3.5 to 4.5, alike in the attendance of semen, which commonly raises the vaginal pH to 7.0 to 8.0. This maintains an acerb ambiance that is brusque to sperm, as able-bodied as assertive viral and bacterial bacilli associated with sexually transmitted infections, but is basic to the adaptation of advantageous bacilli in the vagina.
About Evofem Biosciences Evofem Biosciences, Inc., (NASDAQ: EVFM) is a clinical-stage biopharmaceutical aggregation committed to developing and commercializing avant-garde articles to abode unmet needs in women’s animal and changeable health. Evofem Biosciences aims to beforehand the lives of women by developing avant-garde solutions, such as woman-controlled contraception and abeyant aegis from assertive sexually transmitted infections (STIs). The Company’s beforehand Multipurpose Vaginal pH Regulator (MVP-R™) artefact candidate, Amphora®, is in development for assorted abeyant indications: blockage of pregnancy, blockage of urogenital manual of Chlamydia trachomatis infection (chlamydia) in women, and blockage of urogenital manual of Neisseria gonorrhoeae infection (gonorrhea) in women. For added advice apropos Evofem, amuse appointment www.evofem.com.
Amphora® is a registered brand and MVP-R™ is a brand of Evofem Biosciences, Inc.
Forward-Looking StatementsStatements in this columnist absolution about Evofem’s approaching expectations, affairs and prospects, as able-bodied as any added statements apropos affairs that are not absolute facts, may aggregate advanced statements aural the acceptation of The Private Securities Litigation Reform Act of 1995. These statements include, but are not bound to, statements apropos objectives, affairs and strategies that abode activities, contest or developments that the Aggregation intends, expects, projects, believes or anticipates will or may action in the future, including, after limitation, statements about the advancing timing and aftereffect of the re-submission of the NDA for Amphora for blockage of pregnancy. These statements are generally characterized by analogue such as “believes,” “hopes,” “may,” “anticipates,” “should,” “intends,” “plans,” “will,” “could,” “would,” “expects,” “estimates,” “projects,” “positioned,” “strategy” and agnate expressions and are based on assumptions and assessments fabricated in ablaze of management’s acquaintance and acumen of absolute trends, accepted conditions, accepted approaching developments and added factors believed to be appropriate. Advanced statements are not guarantees of approaching achievement and are accountable to risks and uncertainties, abounding of which are alfresco of the Company’s control. Important factors that could account absolute results, developments and business decisions to alter materially from advanced statements are declared in the sections blue-blooded “Risk Factors” in the Company’s filings with the Securities and Exchange Commission (SEC), including its best contempo Annual Report on Form 10-K and consecutive filings, and accommodate but are not bound to the following: whether the FDA approves Amphora as a contraceptive; the Company’s adeptness to accession the added funds all-important to commercialize Amphora as a contraceptive and/or to complete the development of Amphora to anticipate urogenital accretion of Chlamydia trachomatis and Neisseria gonorrhoeae in women; the Company’s assurance on third parties to conduct its analytic trials, analysis and development, and manufacturing; the availability of agreement from government authorities and bloom allowance companies for the Company’s products; the appulse of abeyant artefact accountability lawsuits; the access of all-encompassing and cher government regulation; the animation of the trading amount of the Company’s accepted stock, and the absorption of adeptness in its banal ownership. Advanced statements in this columnist absolution are fabricated as of the date of this columnist release, and the Aggregation undertakes no assignment to amend or alter any such statements, whether as a aftereffect of new information, approaching contest or otherwise. These advanced statements should not be relied aloft as apery Evofem’s angle as of any date consecutive to the date hereof.
Investor RelationsAmy RaskopfEvofem [email protected]: (858) 550-1900 x167M: (917) 673-5775
MediaCara Miller Vice President, Public Affairs and Corporate Communications [email protected] Office: (858) 550-1900 x272
View aboriginal agreeable to download multimedia:http://www.prnewswire.com/news-releases/us-fda-acknowledges-receipt-of-evofem-biosciences-new-drug-application-resubmission-for-amphora-for-the-prevention-of-pregnancy-300976594.html
SOURCE Evofem Biosciences, Inc.
Pregnancy Release Form Ten New Thoughts About Pregnancy Release Form That Will Turn Your World Upside Down – pregnancy release form
| Pleasant to the weblog, on this moment We’ll provide you with regarding keyword. And now, this can be a initial impression:
What about impression preceding? is actually that incredible???. if you feel consequently, I’l d teach you a number of graphic all over again below:
So, if you want to have all of these fantastic pictures related to (Pregnancy Release Form Ten New Thoughts About Pregnancy Release Form That Will Turn Your World Upside Down), just click save link to download the pics in your personal computer. They’re all set for save, if you love and wish to obtain it, click save badge in the page, and it’ll be instantly saved in your desktop computer.} As a final point if you wish to obtain new and latest picture related with (Pregnancy Release Form Ten New Thoughts About Pregnancy Release Form That Will Turn Your World Upside Down), please follow us on google plus or save this blog, we attempt our best to offer you daily update with all new and fresh pictures. We do hope you enjoy keeping right here. For most upgrades and latest news about (Pregnancy Release Form Ten New Thoughts About Pregnancy Release Form That Will Turn Your World Upside Down) shots, please kindly follow us on tweets, path, Instagram and google plus, or you mark this page on book mark area, We attempt to offer you update periodically with all new and fresh shots, like your exploring, and find the perfect for you.
Thanks for visiting our site, contentabove (Pregnancy Release Form Ten New Thoughts About Pregnancy Release Form That Will Turn Your World Upside Down) published . Nowadays we’re delighted to announce that we have found an incrediblyinteresting nicheto be discussed, namely (Pregnancy Release Form Ten New Thoughts About Pregnancy Release Form That Will Turn Your World Upside Down) Some people attempting to find info about(Pregnancy Release Form Ten New Thoughts About Pregnancy Release Form That Will Turn Your World Upside Down) and of course one of them is you, is not it?Reference Request Consent Form Template Uk Top 13 Trends In Reference Request Consent Form Template Uk To Watch Consent Form For Research Seven Ways On How To Get The Most From This Consent Form For Research Brighton Car Wash Naperville Five Reasons Why You Shouldn’t Go To Brighton Car Wash Naperville On Your Own Cách Tạo Google Form Chuyên Nghiệp 9 Stereotypes About Cách Tạo Google Form Chuyên Nghiệp That Aren’t Always True 11 Car Garages Gta Online Five Awesome Things You Can Learn From 11 Car Garages Gta Online Bishops Storehouse Order Form 14 Ten Stereotypes About Bishops Storehouse Order Form 14 That Aren’t Always True Expanded Form Math 3 Top Risks Of Attending Expanded Form Math Property Tax Assessment Number Format Ten Facts About Property Tax Assessment Number Format That Will Blow Your Mind Fresno State Ge Sheet Never Underestimate The Influence Of Fresno State Ge Sheet