Rebuttal from comments in article about Ampio in Seeking Alpha
A few remarks to accusations, misstatements and hallucinations presented in this misleading article composed by a confessed short seller:
Zertane was not bought from Biovail. Zertane use for premature #$%$ was invented and patented worldwide by Dr Bar-Or for the benefit of Ampio. The combination patents for Zertane with any PDE5 inhibitor are also the properties and inventions of Ampio. Zertane was licensed to Biovail for which Dr Bar-Or's previous company received significant upfront and milestone payments. Biovail conducted the trials in Europe and before their completion was acquired by Valeant who stopped all trials and R&D activities that Biovail was involved with, including the Zertane trials, which were completed by Ampio. Neither Valeant nor Biovail knew of the trial results when that decision was made (blinded studies done by an independent CRO). By contractual agreement everything was returned to Ampio. The results of these successful trials were published in a peer reviewed journal with the highest impact factor in the world for the field of Urology (European Urology). Ampio met with the FDA and a pivotal study for approval in the USA was agreed upon with them. Ampio paid $2mil to Valeant to acquire all the patented technology for the ODT formulation, which adds another layer of protection to Zertane. According to the CEO statements, a big pharma is and was involved. So get your facts together before you slander this company and its officers.
Although both Dr Bar-Or and Mr. Macaluso are free to sell shares, with limitations imposed upon insiders, none have sold even one share to date.
You are correct to point out that capital needs to conduct both the Ampion and Optina trials will cost approximately $13mil spread over almost a year. The costs are minimal in comparison to the multibillion $$$ market size for these indications. You fail to realize, and time will tell, that a deal for Zertane will be far sufficient to cover all or part of these costs. You have the right to doubt this, but as I said, shortly, we will know. But even in your worst case scenario prediction, raising money to conduct these trials will be an insignificant event in comparison to the gains realized from these indications.
Why were the initial trials not done in the USA? The company explained this on numerous occasions. Zertane- done in Europe by Biovail because the perception was that the FDA does not recognize PE as a disease- WRONG!! Ampio met with the FDA and the FDA recognizes PE as a disease condition and apparently was never approached with a drug for approval for this condition. By the way, Zertane is registered for approval in Australia, who accepts the data generated in the phase 3 trials in Europe.
Ampion- initial trials done in Australia because the company wanted to come to the FDA with human data and conduct a pivotal trial in the USA. Also approval in Australia will facilitate approval in at least 13 countries in South America and the Pacific Rim. Indeed the FDA waived all preclinical requirements for Ampion in the pivotal trial.
Optina- Initial Phase 2 was done in Canada because at the time Ampio did not have issued patents (now it has issued patents worldwide) and did not want to register the trial in clinicaltrials.gov for confidentiality considerations.
Since you really are not familiar with the doses and IP positions I suggest you do not make unintelligent statements about the availability and formulation of these drugs until you read and understand all the issued and pending patents surrounding this extensive portfolio. There is a reason why major pharmaceutical companies are knocking on Ampio’s door. Unfortunately for you, you will not know until it’s too late......
I got most of this info by talking with the company and from public records.