EMV 1.97% $1.99 emvision medical devices ltd

Ann: Stage 3 Recuitment Achieved & FDA Engagement Underway, page-18

  1. 4,351 Posts.
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    Positive announcement, positive comments, negative share price movement. Hmmm. Maybe if I throw in a comment that is homoeopathically negative I might reverse the market sentiment.

    I actually think that in the announcement they have been overgenerous in cutting themselves slack.

    "Once all the data is received and verified, it will be analysed with Stage 3 resultsanticipated to be reported during H2 CY2024." Given that it is already H2 CY2024 and given that they already have all the participants they need for Stage 3 they are hardly saying much by telling us the results will be out in the next 6 months. Also they tease that the results of the validation clinical trial could also be out as soon as H2 CY2024 (or maybe later). Surely they could have zeroed in a tiny bit more with the Stage 3 results, say, Q3 CY2024.

    Also the roadmap schematic used in the announcement seems unnecessarily primitive. It looks like a gant chart but every task and event is serialised eg everything associated with the pre-validation tests must be completed - signalled by a dashed line - then everything associated with the validation test must be completed. Not normally how projects roll out.

    Finally, when it comes to engaging with the FDA it is not like delving into the unknown. My understanding is that the FDA has service standards that they stick to. For instance another stock I follow has lodged an application with the FDA and they have been told to expect a response within 90 days of the lodgement. A bit too cute for me for them to clump together the FDA approval process with regulatory processes in other jurisdictions and indicate completion of those processes in 2025 or later. I re-listened to one of Scott Kirkland's presentations and at that point in time he was happy to say that they are shooting for Gen 1 to go commercial in "FY25" aka H1 CY2025. Why the uncertainty now?

    As EMVision starts to move towards commercialisation of its first product they need to build momentum in their marketing. Going vague suggests they either have nerves or they have issues. I think the former but it seems the market worries it might be the latter.
    Last edited by triage: 08/07/24
 
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