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Re: dennisdave post# 702520
Sunday, June 30, 2024 7:06:08 PM
Post#
702745
of 703037
Below is a transcript of LP's "Looking Forward" section regarding the timeline. I'll work on other parts, but I wanted to get this out there in the event that no one else has yet. I think it helps to have the entirety of this section available.
That was only meant to be like a minute but, okay, so now we’re changing focus to forward looking and… let me remind you what I said at the end of the formal meeting which is these are forward looking statements. The actual results could vary materially for lots of different reasons. Please read the risk factors in our SEC filings, and please don’t rely on forward looking statements… so what I’d like to do is just give you a sense of looking ahead, now, for going forward, 18 months or so. What are our priorities that we’re going to be focusing on. I’m grouping them into three groups: our top priorities, our second priorities, and then our, as we can, as feasible, priorities. So I’ll give you the three groupings, and I’ll just describe them.
Needless to say, our top priority, our laser focus is to complete the process and hopefully obtain our first commercial approval the UK. Hopefully approval of the MAA. We’re all underway. We believe MHRA is following the 150 day that they have, but we don’t, we do not have confirmation of that. We don’t have a way to be sure of that… to know it for sure. But we believe that. The hundred and fifty days, quote unquote, involves approximately three stages, and the time frame of each stage is approximate, so it’s not, you know, on the button. The first stage is approximately 80 days of initial review of the application. The second stage is approximately 60 day clock stop when the agency is going to deliver a list of questions to us as they do in all these processes… it’s not just us. They’ll deliver questions, they’ll ask for supplementary information, all of that, and we will try to respond as fast as we can, which is why we’re trying to guess what they might ask and to already be kind of prepared. The third stage, which will come after the 60 day clock stop, or however long the clock stop turns out to be to provide all the answers and additional information. The third stage is approximately 70 days of further review and reaching a decision.
Again, the timelines are approximate. As far as we’ve seen, there is not an equivalent thing in the UK that’s similar to a PDFUA date in the U.S. You know, under the legislation in the U.S., the FDA can have a target date for giving you a decision. We don’t have a target date. It’ll be what it’ll be. Okay. And those approximate time frames of those three stages that I described, of course, depend also on MHRA’s workload, and what backlog they have, and so forth. So that’s the approximate process and approximate timelines. I mentioned, with a lot of emphasis and a lot of discussion about the inspections… if they’re going to inspect every one and everything. Those are going to be going on all during this MAA review process. And those will have to be completed before an MAA decision can be rendered. So there’s going to be extensive inspections and it’s going to be going on during this period.
So we’re going to follow the typical practice of biotech and pharma companies which is we’re not going to be provide interim step, blow by blow, they asked us this, we answered that. They asked us the next thing, we answered that. No, we’re not going to do the interim steps. We’re just going to tell the result when the process is finished. That’s the typical approach, and that’s the approach we’re going to be taking. Linda Powers, June 29, 2024
Personally, I think that last part is important because she's stating, in fact, rather doubling down in stating, that they are not going to tell us at what stage they are at. I know it seems as if she is speaking as if some of these things (RFI and Inspections) haven't happened, and that may be the case. But describing to us in some detail what they haven't had happen yet somewhat flies in the face of her last statement, so we have to consider that she is carefully describing the steps the MHRA follows and giving some details, so that we as shareholders can understand the entire process better.
And as I know Meirluc made the point yesterday... how can the company think they're in this 150 day timeline, and additionally add in the 60 clock off, and not even have reached the first 80 days before a clock off, almost 157 days later from January 24, or 115 days later, if one takes the timeline forward from March 3? Either they weren't given the 150 timeline, and they're instead in the typical NWBO taking forever timeline, or they are in it. And if they're in it, it really doesn't make sense that the MHRA, who have been so rapid in their previous responses (according to LP - e.g. the PIP plan took half the time) and have been so wonderful to work with, would be slogging along at a pace that's almost twice as long (first 80 days had turned into either 115 to 157 days).
Also... no worries about the inspections question... I thought perhaps you'd found something citing that they had to be completed before the RFI was done. We'll all just continue to stumble along and try to make sense out of where they may be at in the process.
AI
