In September 2012, we received the Day 180 List of Outstanding Issues from the CHMP regarding our ADASUVE MAA. However, the Day 180 List of Outstanding Issues included two “major objections,” which preclude a recommendation for marketing authorization at the present time. The first major objection states that the CHMP does not believe that our data supports the broad indication as submitted, and that we should justify that the benefit/risk is positive in this group or identify a group of patients in whom the benefit/risk would be positive. The second major objection is that to limit the risk for, among other risks, bronchospasm and an effect on cardiac rhythms, or QT time, we proposed to limit the use of ADASUVE to a single dose per 24 hours, however, a “considerable proportion,” as described by the CHMP, of patients in the efficacy studies did not respond to a single dose at the 4 hours time point and needed subsequent doses. Therefore, it remains uncertain whether in clinical practice it will be feasible to avoid dose-repetition.
During the fourth quarter of 2012, we plan to submit additional analyses and responses to the EMA in response to the Day 180 List of Outstanding Issues, including the two major objections. We also anticipate a face-to-face meeting with the CHMP during the same time period.
So, the title should be like this " EA REJECTED ALXA"S application" - at anytime sooner.
"If the FDA requires additional Phase III studies"
You didnot read the latest report or don't want to. It clearly states
There were no new clinical or safety issues identified, and there were no other deficiencies outlined in the CRL."""
go down to 20 cents (may be) and pumping will happen (may be to 40 cents) from there before dilution or split. Again, dilution before split and again dilution.
Great F...g Management.