Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Quarterly CC; an explanation on pozi interim data non-release would be nice at the upcoming CC on Thurs. We have interim, almost mature, data on pozi cohort’s one, and, to a lesser extent, cohort 2 but Spectrum is waiting to PR topline for cohort 1 in the 4th Q. Back in post 2536 (TGTX release vs Spectrum non-release of interim data) I was postulating that is the more conservative thing to do but I said this not being fully convinced. And in a follow-up post, 2571, I gave the view of another poster on another board who has dealt w the FDA on the periphery of these matters.

It is very easy on a board to discuss what a company should and should not do in dealing with RA's [Regulatory Authorities], while nothing is more sensitive during a clinical trial prior to top line results being finalized. The reality is that, though there may be some value in doing so for the company or shareholders, when it comes to regulatory discussions with RA's if you have never been there you really have little idea. When, as in this case you are dealing with multiple RA's you have even less idea. Every statement you make about an unblinded trial in progress has jeopardy associated with it and you have to understand the history of all the RA discussions, which are all well documented, even phone calls, in meeting records, and, every word is meticulously measured, as much as possible in discussions and absolutely so in written PR's. These agencies get very upset when companies share things that then turn patients on the RA's demanding information or drug access. Companies are very guarded not to violate any norms, not to over-PR anything, not to violate any discussion agreements or not to divulge anything that does not have to be divulged because it could cause any level of confusion or make the next RA discussions more difficult. Small companies in particular have to be very cautious because they don't have panels of scientists and lawyers to counter RA when/if they get upset.

Still, it would be nice to get Spectrum’s view on why they aren’t releasing interim data either from Spectrum volunteering this info directly or by being asked by an analyst. The reasons can explain why and it would be no big deal on Spectrum’s part to volunteer it and would be nice to hear it from the horse’s mouth. I think it would benefit Spectrum in assuring nothing nefarious is going on, and remove a reason by naysayers to doubt Spectrum’s abilities. Come on Spectrum, give us your reason why you’re not releasing interim data such as at a venue like World Lung. Regarding topline itself, the longer you wait (assuming more efficacy) the better the data will be (e.g. DoR) so do we want to wait that long? For example, if DoR is 9 months w the improvements in the trial vs the ~6.6m in the MDACC trial, that will take us to the middle of October w topline in November sometime. We waited for Godot for Rolontis, I’d hate to invite him to the pozi party w/o a good explanation why.