I'm still optimistic and like the strategy of Acrux. Although...

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    I'm still optimistic and like the strategy of Acrux. Although cash burn is a concern and needs to be monitored closely towards the end of FY22.

    Below words from the CEO report gives me confidence in their ability and reputation in the market. I know it has been slow, but the reasons given is valid and some learnings have been made.

    I will continue to buy.

    My only question is, what is the 5th product approved or under review from the FDA? I know Testosterone, Jublia, EMLA have been approved. Dapsone under review. What is the 5th product?


    CEO Report extract
    Acrux has continued to focus on the development and registration of prescription topical pharmaceuticals that are generics of existing drugs in
    the United States. FDA requirements for the development of topical generics require different skill sets and approaches to bioequivalence when
    compared to the larger oral and injectable sectors of the US pharmaceutical market. The FDA characterises the development and bioequivalence
    of topical generics as complex and indeed some of the in-vitro bioequivalence techniques that generic companies are required to develop are
    known within the industry and Acrux as being technically challenging with significant barriers to successful execution. The Company has spent
    considerable effort in developing its expertise in these areas and uses both in house capabilities as well as a network of external non-clinical
    research organisations to assist in demonstrating bioequivalence of the products it develops compared to the reference listed drug in the United
    States.
    Our approach to the evolution of our pipeline is based on the thorough assessment of new product development candidates as well as the
    financial and human resource capacity of our organisation. Our planning approach to development of new products has evolved and for new
    projects now takes into account our learnings from prior development projects and incorporates increased development discovery work to
    identify and pro-actively assess critical development issues. We know that when we choose to develop products that have few or zero generics
    approved, with no patent protection and annual sales that make the product attractive for development by other companies, that there are
    often reasons why zero or limited numbers of generics exist. Usually, the reason is based on a challenging set of formulation characteristics as
    well as a challenging array of bioequivalence techniques required by the FDA. To Acrux, these challenges are also opportunities and are the
    reason that Acrux receives numerous in-bound contacts from other generic companies, from the United States and other regions, who are
    interested in licensing our products for commercialisation in the United States and other countries. The majority of our products that are in
    development have been licensed to commercial partners for commercialisation, however, we always welcome contact from other potential
    licensees and actively engage with these companies to discuss other non-partnered products.
 
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