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Re: jbog post# 205530

Friday, 10/28/2016 12:12:44 PM

Friday, October 28, 2016 12:12:44 PM

Post# of 257302
In 2.5 weeks or even sooner will see (at AASLD).

The Abbvie Next gen is still not fully known in efficacy and performance in sub groups..

Epclusa is largely known;
for the most part it is 12 weeks, all genotypes.

What we have seen is that the Abbvie 2nd gen could get approved for 8 weeks for some easier to treat groups.
Abbvie says the VAST majority will be 8 weeks

In the USA the major market will be G-1
I think that the 2nd gen will be 8 weeks and superior 12 week SVR rates compared to Epclusa.
It appears that the Abbvie 2nd gen will get a speedier FDA review.
https://news.abbvie.com/news/abbvies-investigational-hcv-regimen-receives-us-fda-breakthrough-therapy-designation.htm
"NORTH CHICAGO, Ill., Sept. 30, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for the investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) for the treatment of patients with chronic hepatitis C virus (HCV) who failed previous therapy with direct-acting antivirals (DAAs) in genotype 1 (GT1), including therapy with an NS5A inhibitor and/or protease inhibitor."

In G-3, an under served and (prior) expensive younger market, I think we will see 8 week TX in some groups and superior 12 week data to Epclusa.
Same deal for past Tx failures compared to Epclusa.

In general, the major competition should be Epclusa.
The Gilead triple will have comparable cure rates, but it may only be used as a salvage treatment.
Even last week some of the data looks a little soft for the Gilead triple.

I look at the USA market as very good.

The Gilead triple didn't hit all of it's trial goals; this doesn't bode well for a so called "salvage" treatment when Epclusa outperformed the salvage triple. (So Epclusa could become the salvage TX for failed triple? : ) )
I'm joking of course, but they are already asking themselves; what do you follow up with a failed triple salvage treatment?

If you don't have a good answer you may see warehousing, or people could get creative such as they did with off label Sovaldi and Simeprevir.
(Abbvie 2nd gen and Sovaldi?- why hasn't Abbvie tried a small group of these?)

Obviously, in 3 weeks we will have a far better idea, but we still won't know the labeling, approval dates, prices and other particulars.

Anyway...just my view (..hope?...), and I have been oh so wrong before. : )

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