Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

I've posted that Spectrum's non-release of interim data is the more conservative thing to do especially w money in the bank

With over 300M in the bank (Spectrum announced the Completion of the Sale of its Marketed Portfolio on Fri), Spectrum can more conservatively wait for top line data later this year. It makes no difference to them since they won’t be doing any financing in the near future.

when comparing it to TGTX that put out a PR on positive interim data and subsequent financing a couple of days later after a 40% increase in SP but I have this Dr Jeckyl and Mr. Hyde thing going on

Bummed by cohort 1 results pushed to 4Q but being a glass half full kind of guy hopefully it's because the DoR is taking longer to mature. Still don't see why they don't report interim results at ASCO or SABCS. We shall see. Come on Spectrum. - post 2568

so it was so apropos when on the NWBO board doingmybest, who worked in Pharma, posted a couple of days later the following w/o any prompting on my part

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.

When I brought up the example of TGTX he replied

I am not familiar with the TGTX circumstances. Things that are taken into consideration are the strength of the science, the strength of the company, the relationship to date with an RA or RA's, the company's overall situation, the status of the trial,... it is an overall risk analysis. What I can say from experience, and, I have experienced tough stances with FDA too, the norm is to accommodate FDA as much as possible to develop cordial and cooperative relationships if possible. IA's are often known by shareholders and companies will often make a statement about results because they are known.

Another poster brought up the example of

OREX [Orexigen] released their interim analysis placebo vs treatment arm numbers without the blessings of the FDA, and today it is OREXQ at 0.01c. The pps shot up but FDA got mad and they did not accept their trial anymore because the trial was unblinded at the interim.

Note - this was a blinded trial so not totally relevant.

So anyhows, this got me thinking again on why doesn't Spectrum release interim data and it just keeps bringing me back to the thought that Spectrum is still discussing BTD w the agency and they don't want to rock the boat. I know, I know, I'm rationalizing here but geez Spectrum for once be ahead of the curve please.