- "Make sure you really need an SPA. It may take longer to obtain one than you think."
- "If you choose to pursue an SPA, be unambiguous in the questions you ask and meticulous in your filing. Be realistic about the timing."
- "Be prepared to explain your reasoning to investors and board members."
- A "final" re-submission sometime in September or October [early- to mid-November], to
- Within 6 weeks or by December 15 [now through mid-December], to
- Foreshadowing by the October 2 PR's specifics regarding the trial design [mid-November], to
- Using math for the September 19 PR first indicating the MM Phase 3 trial would commence in late 2012 or early 2013 [mid-November through at least early-January].
The person on the management team who has had and continues to have the best perspective on SPA timing is Eric. Management had to waive off their base case Q3 expectations using their September 19 PR. The October 2 PR clearly was intended to affirm the SPA was on its way (using trial design specs and quotes by Eric), but no one knows exactly when the SPA will arrive including, I think, Eric.
"It's not a matter of if, it is a matter of when, and we are much closer to the end than we are to the beginning."
Your and my best bet is to keep an eye out for the SPA over the next few weeks, but do not be surprised if it arrives in December (maybe or possibly) or January (I highly doubt). When it does arrive, those who doubt the potential for the SPA to move the share price, thinking it has been priced into the share price (which I think is incorrect) might be surprised.
License deals. Management reminds us they currently are pursuing PH-10 and PV-10 geographic deals, which they think can happen at any time. They remain very confident one or more of these will happen.
More Moffitt data. The October 29 PR (more specifically, the poster included with the PR) noted more Moffitt data is expected in 2013 (the AACR annual meeting). Management is trying to get some information out about Moffitt's ground-breaking results sooner. Moffitt's Phase 1 MOIA human trial to elucidate the bystander effect should begin in November. Turnaround should be swift (i.e., a few months if that).
Surprises? Perhaps, including certain publications in play and other potential surprises, but we will have to wait and see.