Thanks misiu HIV.. -- information about 525
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(Total Views: 421)
Posted On: 11/27/2019 9:23:01 AM
Thanks misiu
I want that answer more than any other. We have been in BLA limbo hell since March. This uncertainly with the BLA has had to do more with the share price drop, than whether or not there is a deal, financing, or anything else imo. It is time for the FDA to give an answer.
Yes, NP meeting with senators. Maybe that is why he wasn't answering emails, he has been busy this last week. This could be huge if announced. Maybe connected with the Army and Sacha?
Anyway think of this, once a month. Assuming the price of yearly leronlimab is 35k a year, the price of PrEP could be as low as 25% or $8k per year. That would be massive, I suspect some see that, which is why the interest.
I don't like he said this focus has delayed mono. They don't have human data in PrEP, other than national headlines. I don't see why it should get focus over mono.
I suspect either the partner is focused on PrEP. I know companies like Gilead think that is the future, so they may be more interested in that than mono. Meaning the potential partner is pushing this harder. Or the FDA said they want more data to decide on mono and this is an easier way to give a timeline extension. The phase 3 investigatory trial is still ongoing with, any issues they would stop it. So I suspect it is one of those two reasons.
Quote:
HIV..
-- information about 525 mg and 700 mg was given to FDA , when they will decide dose of our combo , we will submit part 2 of our BLA and then in December we will submit part 3....
I want that answer more than any other. We have been in BLA limbo hell since March. This uncertainly with the BLA has had to do more with the share price drop, than whether or not there is a deal, financing, or anything else imo. It is time for the FDA to give an answer.
Quote:
--In PrEP , we think that we will need to treat people once a month , not once a week , because , we knew long time ago that with 700 mg VL drops in 14 days ,
Yes, NP meeting with senators. Maybe that is why he wasn't answering emails, he has been busy this last week. This could be huge if announced. Maybe connected with the Army and Sacha?
Anyway think of this, once a month. Assuming the price of yearly leronlimab is 35k a year, the price of PrEP could be as low as 25% or $8k per year. That would be massive, I suspect some see that, which is why the interest.
I don't like he said this focus has delayed mono. They don't have human data in PrEP, other than national headlines. I don't see why it should get focus over mono.
I suspect either the partner is focused on PrEP. I know companies like Gilead think that is the future, so they may be more interested in that than mono. Meaning the potential partner is pushing this harder. Or the FDA said they want more data to decide on mono and this is an easier way to give a timeline extension. The phase 3 investigatory trial is still ongoing with, any issues they would stop it. So I suspect it is one of those two reasons.
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