November 27, 2011


Coming out of the company's second meeting with the FDA earlier this year, the expectation was for a third meeting to resolve remaining design issues related to the pivotal MM Phase 3 trial. Diligence suggested an expectation of a late-June or early-July meeting date. June turned into July turned into...September, when Tim Scott mentioned the upcoming meeting with the FDA at the Rodman & Renshaw conference. Ultimately, the meeting appears to have occurred in October, some 3-4 months later than expected.

What caused such a delay? With the benefit of hindsight and after checking around, it seems the massive FDA reorganization that began, perhaps, in July setback management's attempts to secure their 3rd meeting. As as result, my expectation of the company agreeing to a consensus design by or before the end of the 3rd calendar quarter (September 30th) was incorrect.

I've adjusted my expectation to the end of the 4th quarter (December 31st), as the delay was no fault of their own. They, like several other companies, were caught up in the reorganization.

Let's then keep an eye on two steps of the path before we strike a rendition of Auld Lang Syne: agreement with the FDA on the trial design suitable for an SPA and release of the psoriasis trial results. With luck, our champagne toast may taste that much sweeter.

No comments:

Post a Comment