RE:RE:Easy Money to be made"The CHMP or the Pharmacovigilance and Risk Assessment Committee (PRAC) can convene a SAG during the evaluation of a specific medicine when they encounter specific questions that are best answered by experts in the field, including patients"
The experts in the field as well as the patients are likely to recommend the drug. If they ask for a longer study, they will end up depriving patients of this therapeutic option.
At most, they may ask for more ongoing data collection.
That's my opinion.
bfw
palinc2000 wrote: SPCEO1 wrote: The stock market is such a crazy animal. But it gives those who can keep their head screwed on and take a longer term view of reality great opportunities to make money. This is certainly one of those opportunities.There is no cure for HIV despite the headlines. Those headlines are just fake news but the weak minded, who don't bother to read the actual story or think through the ramifications of what was disclosed, react emotionally and sell. I feel bad for them but in a market, they will always exist.
The Taimed sales issue is also not anything to react to. Bloomberg Trogarzo sales for February do not reflect anything like the Taimed sales for the month.
My best guess is the EMA is just trying to cover themselves by referring Trogarzo to an advisory committee because the there was only one phase III trial and it was small and short. If something bad were to eventually happen to patients regarding side-effects, they just want to be able to point to the advisory committee's approval to cover themselves.
So, the stock is down a ton over the last two days on effectively nothing. If you don't already own too much of TH, it is giving you a brilliant opportunity to buy more. It really is a gift in light of the impending NASH results.
THe stock is not going down on the assumption of a cure for Hiv .Taimed sales were probably known to some yesterday and coud have been the reason for the sell off prior to the press release concerning the manufacturing problem of the labelling (a non event)
The EMA news however is not a non event,,,,Look back at the reasons for rejecting Egrifta in June 2012...They are very thorough in both safety and efficacy
I dont expect safety to be an issue but they may want to wait for more data on a larger patient base for efficacy....Dismissing this news as a CYA decision is taking this a bit too lightly ,This is not a slam dunk ...Can they still approve ...Yes but the risks are now higher today than they were yesterday
BTW I agree taht markets are crazy since there is nothing built up in the SP for European approval but a rejection might create uncertainty with out US doctors