Replies to post #1718 on Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

If they make decisions to include a wider set of patients it could be because of other reasons - f.e. to speed up the enrollement.

I wasn’t seeing it as speeding enrollment since I would think they would increase the # of pts like they are doing in the MD Anderson trial so they could get an accurate read on EGFR pts. If they did what you say i.e. not increasing enrollment then one possibility is what you state i.e Dr. Raj and company is greedy or 2) they have access to data from the ongoing Hanmi mBC trial to make a determination on EGFR and whether to include it in a future pivotal trial in mBC.

Like they decided to cut the rolontis trial to 400 to keep the promise to deliver data in the first half of 2018 and because they where hinted by the FDA that they have to do a second trial - which they take a high risk with only shortly above 200 patients.

My take taken from a previous post is

Regarding the Rolontis trial going from 580 to 400 is promising on several fronts. It always seemed like overkill to me to have 580 pts to test for what essentially is a basic laboratory blood parameter, ANC. This is confirmed in a way by the looking at the # of pts for the EU trial, 218. This is telling me you only need 218 pts to get SS for the trial. And more importantly, what this is telling me is that the FDA is comfortable w the safety profile of Rolontis since they are not expecting any AEs or immunogenicity issues with it and the power to detect such a problem is not helped by having 580 pts. Very big in a way, besides making the trial go quicker it removes an elephant in the room.

So I see it differently from you on this. You may come back and argue that ANC will be variable between patients just like PFS or OS is but the variation is much tamer than giving a drug that’s trying to stop cancer where it may depend on what mutations or # of neo antigens a pt has - lot more variability there. Where I have a concern with Rolontis these days is if Dr. Raj is misstating that the second trial is only needed for EU approval. Several analysts have asked him directly what the second trial is for or whether a second trial is needed for US approval and he always stated that it’s not.