Time line comparison Imetelstat vs Daratumumab

[Fishermangents]

From sdrawkcabeman (YMB), 18 Dec 2015

Genmab announced a partnership with Janssen for exclusive worldwide development and manufacture of Daratumumab on Aug 30, 2012. Breakthrough therapy announced on May 1, 2013. Approval in Nov 2015, 3 years 3 months from the partnership announcement.

Geron announced partnership with Janssen on Nov 13, 2014. We can expect an expedited path to be granted literally any day now. Imet is easily a candidate for all three expedited paths, and rolling review and priority review. JNJ already announced plans to file in 2017, in the best case scenario with priority review, look for approval in mid 2017, less than 2 years from now. Just like Daratumumab, Imet's approval in 2017 will be close to 3 years from the initial partnership announcement, and I think it'll be even shorter than that. The critical difference is that Imet has a larger patient population, and a very serious unmet need in these indications, considering Imet also outperforms the SOC.

JNJ has had several of their drug candidates receive expedited path and approval in the last few years, a well traveled road for them, they understand the rigors of the process and how to optimize their success. No doubt they've built a rapport with their colleagues at the FDA. I think Dr. Richard Pazdur at the FDA is a maverick, and understands the emerging world of modern medicine fresh off the lab, and the urgency driving development. Read interviews with Dr. Pazdur, you'll hear his excitement for the rapid developments, especially in oncology. The summation of all of this gives me the most confidence I've had for the approval of any drug in my memory. The price of entry at these levels is irrelevant, look for approval, keep your eye on the ball. I think the market and the press is just starting to recognize Imet's potential.