RE: Serious Potential Buyers Here? No Chance!1 Oct 2019 13:14
Think you’ve made your point..but keep banging on about it makes people wonder if your motive lol Important thing for me is that Iclaprim is well alive now because FDA have now spelt the success criteria and have committed to this (if as you imply they won’t approve its dead, then why FDA been working collaboratively to map a way forward). So, the way I see it this approval has now been significantly de-risked for potential buyers, hence should see many interested parties knocking on the door here...!
We have worked collaboratively with the U.S. Food & Drug Administration (FDA) to develop a way forward and based on guidance received during the FDA meeting on 19 September, we believe that a single well-designed adequate and well-controlled Phase III clinical trial demonstrating safety and efficacy of iclaprim in patients with hospital-acquired bacterial pneumonia (HABP), including ventilator-associated bacterial pneumonia (VABP), along with data on potential mechanisms of hepatic injury, would enable submission of a New Drug Application for approval by FDA.