this announcement is now issued to ASX but not price sensitive as i think rule suggest $$ needs to be part of the announcement to be "price sensitive" ... for me it is first step of recognition before formal application for gets through to FDA i guess.. we will hear more from @ThaLuvDocta when he/she wakes up... !
i believe .... company probably has no input into this to make announcement first on their website before ASX as there is only a split minute difference between them... i happened to just came online today after few days and was simply checking emails and caught it... !
FDA Breakthrough Device Designations for VITILIGO & Soft Tissue for the RECELL® System, page-4
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