eigmna: "I am wondering whether this positive result was already known. I did not see it in the November 30 announcement."
Invitro tests of gram negative bacterial and AzaSite were done in laboratory testing and published last year. You may review one of the investor presentations and a power point slide lists the results. Some of the same gram negative bacteria were encountered during the human trials of phase III and proved that AzaSite was indeed effective. It totally removes any doubt of a difference between laboratory testing and human trials. Moving AzaSite stongly within the gram negative area makes it highly competitive with the latest quinolones on kill rate alone as the quins are less effective on gram positive bacteria than AzaSite. You can now easily say that AzaSite is at least equivalent to the latest quins and the compliance, faster cure rate, and less side effects will push them well ahead in sales. Everyone will sit up and take notice when the full data is presented at the international ARVO.
Breccia: Yes, all of the bacterial encountered during the trials and the results of treatment will be statistically significant and listed in the submitted NDA.
1. Effective against gram positive and gram negative organisms
2.Effective against azithromycin-resistant bacteria
I am sure that anyone in this business will pick up on these factors.
I remember a few months ago (when I took a stab at trying to comprehend whether this was more than just a "pink eye" drop) that there were discussions about the importance of gram negative and gram positive results of Azasite. Per the latest announcement:
"A wide variety of bacteria was encountered in the trial, including both Gram positive organisms such as Streptococcus Pneumoniae and Staphylococcus Aureus and Gram negative organisms such as Haemophilus Influenzae."
I am wondering whether this positive result was already known. I did not see it in the November 30 announcement.
Also, "Positive top-line results from the first Phase 3 AzaSite clinical trial was released on November 30, 2005. ADDITIONAL analysis on data from this first Phase 3 study indicate that AzaSite is also effective against azithromycin-resistant bacteria." Clearly, this is new info.
Because one is required to parse carefully these announcements, it is no wonder that the market finds it difficult to pick up on this positive info.
A move under a buck will make the ISV Predator a realty again and that cannot happen it will just allow him to start posting his dribble agin,so I am hoping Harding is in the history books forever.Adamo