RE:RE:RE:UpOne analyst did ask about how the NIH guidelines impacted the sales process, phase IV trials and other ways to
I need to relisten to Luc's response to that because I thought it was a good question. My memory is that the guideline and the NEJM articles were simplifying the conversation with physicians but generally doctors understand the new MOA of the drug already. That suggested to me that much is already in place and there is little more to do with respect to new initiatives
palinc2000 wrote: SPCEO1 wrote: Technically, there was one very weak and small piece of guidance on Egrifta - sales were forecast to be higher in 2019.
Frankly, if the NASH results are good, none of that matters in a relative sense. And there is good reason to think the NASH results will be good at some level. I am pretty sure the stock is up on the realization that the NASH results are imminent and because what the company said on the call was new information to many who heard it. We have been talking all about this and more for a while but few are aware of what we have been talking about regarding NASH.
One important thing Christian said was that they would consider doing phase III tests in the general NASH population if the results are good. Obviously, there are some patent issues they would need to deal but that is HUGE if they pursue that. We will get a look at the results soon and I would expect the company to tell us their thinking after sitting down with the FDA and EMA. You will also notice that Christian also said about pursuing approval in Europe for HIV NASH. That alone is a very big deal and very doable if the results are good. Getting the FDDA to add NASH to the Lipo label would seem relatively easy given its safety record, which would likely lead to Egrifta sales that might exceed the current lipo only level, maybe by a lot.
palinc2000 wrote: I think the market reaction is based on Luc’s reaffirming the guidance for Trogarzo for the end of April which was in doubt.... Also the comment that the decrease in Egrifta sales was purely due to inventory management by distributors and maybe the comments about Nash
Unfortunately there was no NEW guidance post April
Another thing that was missing from my wish list is (apart from administrative actions like J code etc) is what new marketing/sales initiatives they are /will be implementing to change the adoption curve in the US for Trogarzo
Did I miss something?