The most recent news update came last week when it was announced that Ampio would move forward with plans to seek an approval for Zertane in Australia. Zertane is a treatment for premature ejaculation for which the company is seeking regional partners globally to bring the product to market. One such deal was announced last year. Newly-signed commercial partner Daewoong Pharmaceuticals Co. Ltd will market the product in South Korea - and seek to combine it with another sexual dysfunction drug - while an update from Brazil last month revealed that FBM Industria Farmaceutica Ltda will look to bring Zertane to market in that country.
Last week questions were raised as to why Ampio is seeking the overseas commercialization of Zertane. Insinuations were also prevalent that the product had no chance of a US approval because of the weak data supporting Phase III trials, which were published in Europe last year.
While it's not uncommon for writers and investors to each come to their own differing conclusions regarding companies and their respective pipelines, it's worth noting that the reason why Ampio is not seeking a US approval for Zertane in the treatment of PE is quite simple - the FDA does not recognize the condition as a medical need.
That fact has been discussed on numerous occasions by the company and other websites who follow the company. Investors should not, in my opinion, base an investment in Ampio on the hopes that Zertane is going to be approved in the United States, because unless the FDA changes its view on PR, that's not going to happen - hence the regional partnerships around the world that the company seeks.
The more cautious investor may shy away from investing in a company that looks to see if a product works overseas first before then concentrating on the FDA in an effort to save a few dollars, but others may be attracted to a business model that might not leave a company as exposed to the loan shark financing deals that are prevalent in the US to keep the early stages of the pipeline going.
Cytosorbents, Inc. (CTSO) is another company that keyed in on Europe before setting sights on the US market and Prolor Biotech (PBTH) is concentrating on both markets simultaneously.
For full report visit: http://vfcsstockhouse.com/blog/article/-ampio-pharmaceuticals-ampe-multiple-pipeline-strategies-with-potential
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