{ "docId": "019de075-4481-714f-9573-a4ad96e0f148", "docSlug": "816ee2fbc8fb2bf52edc4f2891aaa98f", "documentTitle": "Dare Bioscience | Investor Presentation Deck | 27 slides", "authorId": "dare-bioscience", "authorName": "Daré Bioscience", "documentKindSlug": "pitchdeck", "documentKindLabel": "Pitch deck", "sourceTypeSlug": "investor_relations", "sourceTypeLabel": "Investor relations", "presentationDate": "2023-07-01 00:00:00", "orientation": "landscape", "aspectRatio": 1.2938006, "pageNumber": 9, "pageCount": 27, "prevPage": 8, "nextPage": 10, "slideType": "appendix_disclosure", "function": "cite_precedent", "density": "overcrowded", "nDataPoints": 0, "notes": "This slide outlines regulatory requirements for clinical trial design, including placebo run-in periods, patient population definition, PRO instruments, and primary endpoints.", "elementsJson": null, "metadataConfidence": 1, "imagePath": null, "slideHref": "/slides/019de075-4481-714f-9573-a4ad96e0f148/9", "deckHref": "/decks/019de075-4481-714f-9573-a4ad96e0f148", "deckJsonHref": "/decks/019de075-4481-714f-9573-a4ad96e0f148.json", "deckAnchorHref": "/decks/019de075-4481-714f-9573-a4ad96e0f148#slide-9", "components": [ { "bbox": { "h": 0.106, "w": 0.816, "x": 0.092, "y": 0.622 }, "kind": "list", "text": "The change from baseline in the number of satisfying sexual events (SSEs)\nThe change from baseline in the level of sexual interest or desire\nThe change from baseline in the level of sexual arousal\nThe change from baseline in the level of distress", "attrs": null, "subkind": "bullet", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "37d8de13-07f9-4433-924c-7ac08f9365a8", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.043, "w": 0.816, "x": 0.092, "y": 0.537 }, "kind": "paragraph", "text": "The FDA encourages sponsors to conduct trials in a well-defined patient population. This is particularly relevant for sponsors who propose to study women with FSIAD", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "5108a807-fec9-4caa-9075-d08468913d09", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.021, "w": 0.816, "x": 0.092, "y": 0.779 }, "kind": "paragraph", "text": "Definitions of a responder demonstrating improvement in SSEs, interest, desire, arousal, or distress also can be assessed as secondary endpoints.", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "5ee4eafc-d056-4915-ae87-57708f12e4f9", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.021, "w": 0.816, "x": 0.092, "y": 0.58 }, "kind": "paragraph", "text": "It is essential that sponsors use well-defined and reliable PRO instruments", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "605a0857-2a6c-42d4-b466-84b707ef4f4f", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.085, "w": 0.816, "x": 0.092, "y": 0.281 }, "kind": "paragraph", "text": "The purpose of this guidance is to assist sponsors in developing drugs for the treatment of low sexual interest, desire, and/or arousal in women. This guidance focuses on conditions of low sexual interest, desire, and/or arousal that cause marked distress or interpersonal difficulty in women, including female sexual interest/arousal disorder (FSIAD), hypoactive sexual desire disorder (HSDD), and female sexual arousal disorder (FSAD).", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "915a3b45-4ee7-4930-994d-2476e5daa65b", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.021, "w": 0.816, "x": 0.092, "y": 0.601 }, "kind": "paragraph", "text": "The following outcome measures can be used as primary endpoints:", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "94905eb3-6b29-41a2-bb96-2f7c0125eb7e", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.128, "w": 0.816, "x": 0.092, "y": 0.409 }, "kind": "paragraph", "text": "For Phase 3 each trial should include at least 24 weeks of blinded treatment to allow demonstration of effect onset and persistence while on treatment. For a drug intended for use as needed, determine the time period following each dose of the investigational drug when the drug likely to exert its effect, taking into account pharmacokinetic/pharmacodynamic relationships. This information should inform key aspects of the phase 3 trial design, such as the time interval following drug administration for assessing efficacy and the appropriate recall periods for patient reported outcomes (PRO) instruments.", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "a0af3787-16dd-408d-8063-3323ed836fb8", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.043, "w": 0.816, "x": 0.092, "y": 0.366 }, "kind": "paragraph", "text": "Placebo run-in period is recommended for assessing whether subjects will likely adhere to the proposed dosing regimen through the trial and for obtaining baseline data for the key efficacy measures.", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "a9493a67-8f71-40cb-9be3-54c95ba2ca24", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.021, "w": 0.816, "x": 0.092, "y": 0.748 }, "kind": "paragraph", "text": "The primary efficacy analysis should demonstrate a clinically meaningful treatment benefit that is statistically significant.", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "be5670d0-a50d-41fc-a9fb-1d80a1dd92f1", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.045, "w": 0.604, "x": 0.198, "y": 0.198 }, "kind": "title", "text": "FDA 2016 Draft Guidance Document - Highlights", "attrs": null, "subkind": "headline", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "25c3cc4e-fffd-4b0b-ad1f-bb27eb6abf61", "frameworkName": null, "frameworkSlug": null } ], "metrics": [], "tools": [], "frameworks": [], "arcBeats": [ { "to": 13, "from": 8, "beatId": "62556c1f-0dae-4aea-8929-81d2d36a8468", "arcName": "Problem-Agitate-Solution", "arcSlug": "problem-agitate-solution", "beatName": "Problem (Identify pain)", "beatSlug": "problem-agitate-solution-problem-identify-pain", "evidence": "Slides 8-13 present FSAD as a distinct sexual dysfunction, its clinical issue, and the patient's experience", "position": 0, "confidence": 0.8, "parentBeatName": "Complication", "parentBeatSlug": "complication" } ], "loops": [ { "to": 15, "from": 8, "name": "Cost Of Inaction", "slug": "27-cost-of-inaction", "bestFor": "Urgent budget requests, compliance, risk mitigation", "matchId": "946bdaf4-2f0d-4bd9-b675-a10399e70a25", "evidence": "The deck implies that not treating FSAD has significant consequences, but does not explicitly state the cost of inaction", "position": 0, "objective": "What is the cost of not treating FSAD?", "structure": "The Status Quo -> The Hidden Costs Accumulating -> The Future State of Inaction -> The Tipping Point", "confidence": 0.6, "description": "Quantify what happens if the audience does nothing" } ], "imagePathAlt": null, "thumbSrc": null, "thumbSrcAlt": null, "locked": true }