" Innovative regulatory approaches supporting data generation for an indication, such as through an evolutionary, step wise PIP should be considered. Meaningful data generation through clinical trials, supported by compassionate access / expanded access and collecting and using real-world data could be explored as a means (if meaningful data available) to support innovative regulatory approaches to obtain an indication."
Not long now before the penny drops that a shorter approach toward FDA is on the cards....
@needle..... I will never say you are wrong. All I have ever ever said was that the sell off on the Agile announcement was an over reaction as nothing factually has changed about the drugs know efficacy, safety and continuing trial take up with third parties.
Yes Agile may have been a botched approached but it is still going to yield high quality data for us at very little cost. Patient recruitment has been solid unlike my friends over yonder and that is always a good sign that the Dr's and clinicians are on board promoting the trials.
KZA Price at posting:
16.0¢ Sentiment: Buy Disclosure: Held
