{"id":133598,"date":"2018-09-13T05:20:35","date_gmt":"2018-09-13T09:20:35","guid":{"rendered":"https:\/\/www.countingpips.com\/?p=133598"},"modified":"2018-09-12T20:21:21","modified_gmt":"2018-09-13T00:21:21","slug":"biopharmas-positive-fda-meeting-outlines-path-forward-for-trial","status":"publish","type":"post","link":"https:\/\/www.investmacro.com\/forex\/2018\/09\/biopharmas-positive-fda-meeting-outlines-path-forward-for-trial\/","title":{"rendered":"Biopharma’s Positive FDA Meeting Outlines Path Forward for Trial"},"content":{"rendered":"
September 13, 2018<\/div>
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By The Life Science Report<\/b><\/p>\n

Source: Streetwise Reports<\/em> \u00a0\u00a009\/11\/2018<\/a><\/b><\/p>\n

A ROTH Capital Partners note explained the outcome of the t\u00eate-a-t\u00eate and its implications.<\/p><\/blockquote>\n

In a Sept. 6 research report, analyst Yasmeen Rahimi with ROTH Capital Partners relayed that Dar\u00e9 Bioscience Inc. (DARE:NASDAQ)<\/a> “secured a win” during its recent Type C meeting with the U.S. Food and Drug Administration (FDA) regarding the biopharmaceutical company’s upcoming Phase 2b trial evaluating topical sildenafil as a treatment for female sexual arousal disorder (FSAD).<\/p>\n

As Dar\u00e9 had hoped, the FDA approved its use, as two primary efficacy endpoints in its study, of patient-reported outcome measurements that differ from those the agency recommended in its 2016 Draft Guidance from 2016, which were heightened sexual satisfaction and arousal.<\/p>\n

The endpoints the company will now use are improvement in personal distress and genital sensation of arousal.<\/p>\n

This change matters to Dar\u00e9, Rahimi noted, because the FDA-recommended patient outcomes pertain to hypoactive sexual desire disorder, or a lack of sexual desire, whereas the new endpoints are better suited for patients with FSAD, as they are unable to reach or maintain sexual arousal. “In our view, co-primary endpoints for improvements in arousal and distress align more closely with FSAD and the intended biological mechanism of sildenafil,” he added.<\/p>

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Also during the meeting, Dar\u00e9 and the FDA agreed upon a design for the Phase 2b study of topical sildenafil in FSAD. It will consist of two components. The first will be a “content validity study,” in which patients will not receive the drug. Rather, their “comprehension of patient-reported arousal and distress measurements will be tested to isolate assessments most important and relevant” to them. This part is already underway.<\/p>\n

Following completion of part one, Dar\u00e9 will meet again with the FDA to review and ensure the patient-reported outcomes will still work in the study’s next phase. The meeting is likely to occur in 2019.<\/p>\n

For that second study part, which is to take place at home and last 12 weeks, 450 patients will be enrolled and divided evenly between three cohorts: those getting dose A, those getting dose B and those getting a placebo. The objective of the study is to show efficacy in pre and postmenopausal women. “It will also incorporate inclusion\/exclusion criteria that fit the FSAD diagnosis definition,” Rahimi wrote.<\/p>\n

ROTH has a Buy rating and a $6 per share 12-month target price on Dar\u00e9, whose stock is currently trading at around $1.00 per share.<\/p>\n

Sign up for our FREE newsletter at: www.streetwisereports.com\/get-news<\/a><\/p>\n

Disclosure: <\/b>
\n1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
\n2) The following company mentioned in this article is a billboard sponsor of Streetwise Reports: None. Click here<\/a> for important disclosures about sponsor fees.
\n3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
\n4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer<\/a>. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
\n5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and\/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article, until one week after the publication of the interview or article.<\/p>\n

Disclosures from ROTH Capital Partners, Dar\u00e9 Bioscience Inc., Flash Note, Sept. 6, 2018<\/i><\/b><\/p>\n

Regulation Analyst Certification (“Reg AC”): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.<\/i><\/p>\n

Within the last twelve months, ROTH has received compensation for investment banking services from Dar\u00e9 Bioscience, Inc.<\/i><\/p>\n

ROTH makes a market in shares of Dar\u00e9 Bioscience, Inc. and as such, buys and sells from customers on a principal basis.<\/i><\/p>\n

Shares of Dar\u00e9 Bioscience, Inc. may be subject to the Securities and Exchange Commission’s Penny Stock Rules, which may set forth sales practice requirements for certain low-priced securities.<\/i><\/p>\n

Within the last twelve months, ROTH has managed or co-managed a public offering for Dar\u00e9 Bioscience, Inc.<\/i><\/p>\n

ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months.<\/i><\/p>\n

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( Companies Mentioned: DARE:NASDAQ,
\n)<\/p>\n

<\/a> <\/a><\/div>\n

\"\"<\/p>\n","protected":false},"excerpt":{"rendered":"

By The Life Science Report Source: Streetwise Reports \u00a0\u00a009\/11\/2018 A ROTH Capital Partners note explained the outcome of the t\u00eate-a-t\u00eate and its implications. In a Sept. 6 research report, analyst Yasmeen Rahimi with ROTH Capital Partners relayed that Dar\u00e9 Bioscience Inc. (DARE:NASDAQ) “secured a win” during its recent Type C meeting with the U.S. Food […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-133598","post","type-post","status-publish","format-standard","hentry","no-post-thumbnail"],"_links":{"self":[{"href":"https:\/\/www.investmacro.com\/forex\/wp-json\/wp\/v2\/posts\/133598","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.investmacro.com\/forex\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.investmacro.com\/forex\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.investmacro.com\/forex\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.investmacro.com\/forex\/wp-json\/wp\/v2\/comments?post=133598"}],"version-history":[{"count":2,"href":"https:\/\/www.investmacro.com\/forex\/wp-json\/wp\/v2\/posts\/133598\/revisions"}],"predecessor-version":[{"id":133610,"href":"https:\/\/www.investmacro.com\/forex\/wp-json\/wp\/v2\/posts\/133598\/revisions\/133610"}],"wp:attachment":[{"href":"https:\/\/www.investmacro.com\/forex\/wp-json\/wp\/v2\/media?parent=133598"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.investmacro.com\/forex\/wp-json\/wp\/v2\/categories?post=133598"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.investmacro.com\/forex\/wp-json\/wp\/v2\/tags?post=133598"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}