<a id="bm-comp-7a3c88de-014a-40f9-915c-63235e23d84c" name="bm-comp-7a3c88de-014a-40f9-915c-63235e23d84c" class="BMCustomAnchor"></a><table><tr><td bm-component-id="7a3c88de-014a-40f9-915c-63235e23d84c" style="vertical-align: top; width:100.000000%;"><ul><li><font color="#000000">CRL questions SPARKLE endpoint analysis; re-read rejected</font></li><li><font color="#000000">Ascelia disputes both points; <font color="#000000">expresses confidence</font></font></li><li><font color="#000000">Type A meeting next; outcomes range widely</font></li></ul></td></tr></table><a id="bm-comp-2b4dfe49-b6f6-4bc6-a192-6cac685a32b8" name="bm-comp-2b4dfe49-b6f6-4bc6-a192-6cac685a32b8" class="BMCustomAnchor"></a><table><tr><td bm-component-id="2b4dfe49-b6f6-4bc6-a192-6cac685a32b8" style="vertical-align: top; width:100.000000%;"><h3 class="bm-h3">The CRL's stated grounds</h3><p><font color="#000000">In the CRL (Complete Response Letter), the FDA states that SPARKLE failed its co-primary endpoints on the initial read, and rejects the subsequent re-evaluation on two grounds: i.) a risk that new readers were influenced by prior knowledge of the images/results; and ii) a scoring scope limited to T1-weighted images, which the FDA says cannot show added value over standard-of-care imaging (which includes non-T1 sequences).</font></p><h3 class="bm-h3">Ascelia's response</h3><p><font color="#000000">The company disputes both points. It states the second reade<font color="#000000">rs had no prior knowledge of the images or earlier results, directly countering the FDA's bias concern. On imaging scope, the FDA's comment concerns what was <em>scored</em> in the re-read, while Ascelia's statement concerns what was <em>acquired</em> in the trial (confirming T1, T2 and DWI sequences were all collected), a distinction the company appears confident resolves the concern once clarified with the FDA. Ascelia also states its re-read approach was discussed with the FDA pre-submission, though the CRL itself does not address this either way. On product documentation, management seems confident and expects resolution in the near term.</font> Overall, Ascelia maintains that SPARKLE was an adequate and well-controlled pivotal study providing a robust basis for evaluating Orviglance, while remaining confident the product documentation issues can be resolved in the near term.</font></p><h3 class="bm-h3">What's next?</h3><p><font color="#000000">Ascelia maintains that it will submit a briefing package and request an expedited FDA Type A meeting, which, if granted, is typically held within 30 days of the request. Outcomes could range from a relatively quick resolution based on clarification alone, to a further re-read scoring the full set of acquired sequences rather than T1 only, or, in the worst case, a ne<font color="#000000">w pivotal trial with fresh patient data, a materially tougher and likely unfeasible scenario given the funding and timelines required. While the FDA</font> has historically applied a stringent standard when reviewing CRL responses and may ultimately require a more extensive path forward, management's confidence suggests it expects one of the faster outcomes. Valuation remains suspended until there is more clarity.</font></p></td></tr></table>