All of the quotes below are taken from
The 7/24/23 Webcast
The 7/24/23 Webcast
Quote:We have made substantial progress on the HIV partial clinical hold including the hosting of an advisory board meeting comprised of HIV patient advocate and Key Opinion Leaders which has been the next major milestone in our resubmission process which we will further discuss in a minute. In addition, we have added impressive, well experienced advisors to work on this submission. This continues to be the top priority of the company, in order to restore credibility with the FDA and to continue advancing this molecule.
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.
Quote:20:18: I do want to take a moment to thank everyone for their patience with the clinical hold submission as it has been a long and weary road. And it continues to take the company time to insure it submits a high quality submission that meets and exceeds the expectations of the FDA. We have brought on and continue to bring on, new advisors and consultants with the relevant clinical medical and regulatory acumen and expertise to assist us in insuring that we provide the FDA with what they are requesting of the company. At this point in time, I can say that our team, advisors and experts, are quite happy and optimistic about how things are shaping up with the current submission. We believe taking the time to bring in engaged additional professionals is allowing us to put our best foot forward and positioning us for a successful submission.
Quote:And although it has taken us longer than expected on the clinical hold, these delays are not due to new issues or problems but rather time well spent by the company and its advisors insuring our submission is of the upmost, highest quality, adequately addresses, all of the FDAs concerns and requests and puts the company in the best position of being successful. We feel very optimistic and positive about what is being done with the current submission. The efforts to get this company back into a place to proceed forward has taken some time. However, we do believe, that the current team, advisors and strategy that we have in place, we are in the best position to date to be successful.
Thank you everybody for your time today.
9
