PCK 3.45% 3.0¢ painchek ltd

US FDA Approval

  1. 722 Posts.
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    When i load into a stock for a fundamental play i am always wanting to see management release announcements to indicate to me they are moving forward and they are achieving the milestones and targets they set themselves. I average up as it is de risked, i stage out as they miss milestones and risk remains or increases.

    So far milestones are being hit, the company is progressively de-risking and the growth in the market cap valuation occurs as the company becomes a bona fide revenue making business. Pure Start up to Growth company storyline you want to be exposed to....

    So now i naturally turn to the next milestones and apart from the commercial contract of the product here in Australia which will be a big key milestone announcement particularly for instos to see and step into the market, i am looking beyond the wider global picture and the envitable market of the USA.

    Many other past stocks listed have enjoyed big re rates when they indicate to the market their intention of a FDA approval and hence USA commercialisation. We saw this in many ways with RAP with the promotion of the company last year spruiking a FDA route first up. Many companies have big lifts in valuation when FDA is submitted and then announced as being approved. I am sure posters have anedoctal stocks of this being the case........

    So i turn to the latest investor presentation by EPT back in July where the FDA approval is planned for Q1 2018. Now of course to get approval you need to submit, so given my recent research has seemed to show about a 90 day approval process i am thinking that a FDA submission might be right at the back end of this year or perhaps in Jan 2018. The exact timing is irrelevant but given we are moving into Sept 2017 we likely have a FDA approval to use the app within 6 months, not a long wait...well for me anyway on fundamental plays...

    so with the following milestones aiming to be achieved
    Commercialisation milestone for Aust
    Commerialisation milestone to follow in Europe
    Submission and then FDA Approval of dementia App in USA
    Updates on the development of the Kids app.

    all within the next 6 months there is a lot of value add and excitement to come for this company......i look forward to reading more announcements by the company on the above topics
 
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