Spurious?
For me this sounds more and more like FDA is guiding Cytodyn for some time now. In regards of the destroyed reputation of Cytodyn (thanks again Nader, Kelly and AMAREX) and the (for FDA and shareholders) nerve wrecking BLA fuckero, I cannot really blame them. I assume they were as much pissed as I was, this must have been like the three stooges (Nader, Kelly and Kazampoo) were trying to file a BLA at FDA.
It is a pain in the ass now but if we get over the last hurdles we will have a very good relationship with FDA again, reputation restored and ready to rock.
Why FDA is doing this during this clinical hold process (= hurting Cytodyn) is an interesting question and I really hope they are not playing games with us this time.
For me this sounds more and more like FDA is guiding Cytodyn for some time now. In regards of the destroyed reputation of Cytodyn (thanks again Nader, Kelly and AMAREX) and the (for FDA and shareholders) nerve wrecking BLA fuckero, I cannot really blame them. I assume they were as much pissed as I was, this must have been like the three stooges (Nader, Kelly and Kazampoo) were trying to file a BLA at FDA.
It is a pain in the ass now but if we get over the last hurdles we will have a very good relationship with FDA again, reputation restored and ready to rock.
Why FDA is doing this during this clinical hold process (= hurting Cytodyn) is an interesting question and I really hope they are not playing games with us this time.
Quote:17:25: Next we will be providing update on the clinical hold submission. As mentioned earlier, this has been the #1, top priority of the organization. We have made substantial progress in our clinical hold resubmission and have been diligently hard at work, working through the consideration, received from the FDA, there in our most recent meetings with the agency. In particular, the agency, specifically asked us to obtain expert opinion and feedback from HIV patient advocates and Key Opinion Leaders regarding the HIV subpopulation they believe to benefit from LL when taking into consideration HIV drug approvals in recent years, in particular, the -MDR population. The agency has opted to consider the HIV population base, identified by these experts, to determine which would be of benefit, and to then update our response, taking into consideration, this population base, and updating our Risk / Benefit Analysis, General Investigational Plan and Preparing A Clinical Trial Protocol.
We are pleased to announce that we held an advisory board meeting just over a week ago to solicit this feedback requested by the FDA. We had a stellar turnout for this meeting although it did take some efforts to coordinate the various experts and the attendance of Key Opinion Leaders, there was great enthusiasm for LL, the potential they believe it has, and the various patients they believe it can still provide benefit to when taking into consideration the additional HIV drug approvals in recent years. The outcome of this meeting resulted in the identification of 5 potential HIV populations.
19:30: We are now diligently working on identifying and narrowing this down to the single most appropriate sub population. We expect to have the subpopulation narrowed down in the coming 2 weeks, and assuming everything goes according to the current time line, we would expect to resubmit our response during the month of September to the FDA. That being said, our submission will be made only when our experts believe, it is in a high quality, final complete state. This again, is to insure that we deliver a high quality filing, and continue rebuilding our credibility with the agency.
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