Pre FDA Meeting held yesterday
We refer to your letter dated 11 March 2016 in relation to the recent increase in the Company’s share price and trading volumes and respond as follows in line with your numbering:
1. The Company is not aware of any information concerning it that has not been announced to the market that, if known by some in the market, could explain the recent trading in its securities.
2. Not applicable.
3. The Company refers to its announcement made on Monday, 7 March 2016 regarding a memorandum of understanding with a leading humanitarian organisation and UniQuest to enter into a partnership to field test ResApp’s smartphone-based pneumonia diagnostic tool in the developing world. The Company believes this announcement was well received by the market resulting in increased trading in the Company’s securities.
In addition, the Company’s Managing Director, Dr Tony Keating has been in the US this past week presenting to a number of investors, partners and potential clinical study collaborators. Furthermore, a pre-submission meeting was held with the Food and Drug Administration (FDA) at 2pm (US EST) on Thursday, 10 March 2016 (being 6am Sydney time, 11 March 2016). As previously announced, this pre-submission meeting was to take place in the current quarter to discuss the Company’s regulatory pathway to FDA approval.
4. The Company confirms it is in compliance with the Listing Rules and, in particular, Listing Rule 3.1.
Yours faithfully
Nicki Farley
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