RE:Insider Buy, Fostemsavir results and 2019 filing Definitely worth following.
Puts the TH news release on 48 week data today in context. Trogarzo appears somewhat more efficacious. By the time Fostemsavir is on the market, will other formulations/delivery methods of Trogarzo be available. Oral tab ?daily vs sc injection every 2-4 weeks? It may all come down to efficacy and cost at that point.
Anyway, we’ll need to see the full data release from Viiv to know more...
bfw
SPCEO1 wrote: Borad member Dale Wiel once again took her board fee in rights to buy shares, which is effectively an insider purchase of the stock.
Meanwhile, ViiV reported 48 week Fostemsavir results, which looked good on the surface to a non-medical guy like me, and said they would file for FDA approval in 2019. Normallly, company's say they will file in "the first quarter of 2019" or "the latter half of 2019. I am not sure why Viiv left such a wide space open for when they actually will file with the FDA but Fostemsavir's prpgress, or really alck thereof, has beena big mystery to em all along. It was once pretty clsoe to THERF in the development process but fell well behind and got very quiet about Fostemsavir. I wondered whether they were giving up on the drug. In any event, it looks like they will not be a significant force inthe MDR market until early 2021 or so. A lot depends on when in 2019 they do actually file with the FDA, then you have the normal FDA delays and then the normal reimbursement delays.
NBF's analyst has written a short note on this development and is not changing his forecasts as he had already incorporated it into his numbers.
Since Fostemsavir is a pill, it could cause the Trogarzo sales curve to roll over a bit faster than expected in years 4 and 5 but TH should be able to build up a very signifcant number of patients before any competition shows up (CYDY is saying they will file PRO 140 with the FDA in 1Q19 but it is not clear that will matter much as they have no money or marketing partner lined up). The other open question is how will ViiV price Fostemsavir and will that have any impact on Trogarzzo's pricing or competitive positioning. We will see a lot of growth with Trogarzo between now and when Fostemsavir is a actual competitor but for the first time, we can see an potentially competitive product on the horzion.