Would an 8 wk approval for Gild be considered a negative for Abbvie ? After all, Gild already has a convenience factor over Abbvie and Abbvie would also need to get an 8 wk approval also.
Did you happen to know whether Abbvie has asked for both 8 and 12 wk regimen ? tia.
I think you may have more clearly or briefly commented here; http://investorshub.advfn.com/boards/read_msg.aspx?message_id=96802014 "Of course, it remains to be seen whether the FDA/EMA will go along with GILD’s requested labeling—particularly the omission of ribavirin in treatment–experienced patients, where foregoing ribavirin lowered SVR12 by almost 3% in the ION-2 study "
Except I would added [duration of treatment,+/or inclusion of RBV] to your post
My remark is borne somewhat from my frustration in trying to get a clear understanding of the breakdown of response rates in Gilead's trials.
They ended up blending the results; cirrhotic results are blended in with easier to treat less damaged patients.
It also seemed to me that I was unable to come up with information on geno 1A response rates compared to 1B response rates.
Generally speaking, the trials and the information (or lack thereof) released by Gilead which would illuminate the distinctions seem designed to make it hard to directly compare the Gilead program to the Abbvie program.
Since it seems to be a given that the two treatments have comparable cure rates,
but it is also a given that the Gilead seems to be at it's very best in treating TX naives with minimal damage,
then,
would it not make some sort of sense that it might be inferior for some specific groups, in some durations or in the absence of treating with ribavirin?
Abbvie laid out trials where the results were very clear for certain groups. Gilead's trials seem designed to defy comparison.
Both are great programs, obviously and a huge improvement over older forms of TX.
My contention is that there may be some grey area patients groups that might be better served with longer treatments, or treatments with the addition of ribavirin.
Gilead may not want that type of comparison to be made. They want to "sell" the idea that it is One pill, Once a day (and for 8 weeks).
IF it were only Gilead's treatment being considered this fall....then they would certainly get a pass on all they ask for.
The question is, given a higher cure rate using RBV or in extending the duration, might the FDA be justified in not giving Gilead all they ask for? I suppose that they can punt and let the doctors or payors sort it out.
I guess this is typical; the same thing occurs with other drugs, or has for years; numerous trials using Pegasys and Pegintron obfuscated the differences for years; and there WAS an efficacy difference.
Will the FDA approve? Yeah, almost certainly.
Could Vertex have possibly increased the SVR rate with a SOC 4 week lead in and cured an additional 4% of those who treated? Possibly, but marketing won out. The impression that Telaprevir/Incivek was stronger than the competitor and therefore did not need a SOC lead in carried the day. Marketing, after all may trump science.
Conspiracy theory aside.. : )
It may also be that the cutting edge treatments have an embargo of sorts on information so as to not aid their competitors develop their own programs. We see other companies using Sovaldi as a proxy so that they can attain their own data. Maybe it is as simple as that, but also maybe not.
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