InvestorsHub Logo

oc631

09/13/14 11:09 AM

#598 RE: willyw #597

if the comparator trials were required, might (hypothetical) 2nd/3rd generation trials)Abbvie trials be able to use their own product, since they may also be considered the SOC (standard of care)?





Yes that's a possibility. The funding burden on these larger companies is nominal due to their scale. The threat here is to the small developers that are behind in the clinic. I suggested the active comparator may be determined on a class combo specific basis but the final objective is the same so this is unclear. Another advantage the incumbents had running open-label studies is patient screening (cherry-picking) lead to higher SVR rates. Patients in a non-inferiority study will be randomized and blinded to investigators. Enrollment may be slower due to the availability of existing oral treatment options and reduced warehousing.






frontiers

09/13/14 12:07 PM

#600 RE: willyw #597

Maybe the Enta Abbvie 2nd gen will be under the wire. It would make some of the acquisitions dicey; such as ACHN.




that's a BIG maybe ... anyway the Enta/ Abbvie combo lacks a nuke ... hence it will not competitive against the GILD combo of 400 mg sovaldi + 90 mg ledapasvir QD which provides a 8 week cure ... MRK is developing a combo with their own nuke (IDX 21437) and NS5A and PI for 6-8 week cure ... Abbvie/ Enta cannot catch up with either GILD or MRK with their combo ... they may get a small slice of the market, if any at all ... ACHN's nuke 3422 is a close analog of sovaldi and I expect it will be equal to or better than sovaldi in safety and efficacy ... the 3422 POC trial is underway .. run by Ed Ganes in NZ ... Ed also ran the trials for IDX 21437 and GILD 7977 (sovaldi) ... results will be out in a few weeks ... I expect ACHN will be a prime acquisition candidate for 3422 ... as well as for its NS5A (3102) and PI (2684) ... all three pieces are valuable to companies like BMY, Roche, J&J, even AbbVie ... I expect these companies will bid as much $10 billion to acquire ACHN before March 2015 ...