Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Does the conservative approach bode well for pozi BLA filing? Listen, I’m not completely sold on SPPI choosing to remain blinded in an open label trial but it just might be I don’t know enough about this stuff. It could be when you have a registrational trial, it’s a safeguard you want to take. Perhaps, if they received BTD, they would be more aware of the data since there would be constant communication w the FDA. But since they did choose to remain blinded, you have to think the FDA will look at the trial as being Adequate and well-controlled (AWC) similar to a blinded P3 trial and look at it more favorably (Didn’t poster KU say that Spectrum was finagling the data to get a better ORR? Highly unlikely). And perhaps knowing that Spectrum didn’t influence the data, the FDA will be a little bit more at ease in reviewing the data. Anyhows, it can only help the review process.

Assuming you do almost concurrent visits by the Clinical Research Associate to inspect the data at the sites, etc., you’d have only a few of the very last patients to confirm the data. And the last patient 6 months after the dose, is July so you’d have to think a PR on Top Line is right around the corner. Any bets on getting pozi topline before the Rolontis filing? Actually, I hope PRs for both are right around the corner. Here’s an excerpt paraphrasing what was said about being blinded from yesterday’s CC.

“We didn’t want any analysis done until there’s a full 6 month follow-up on last patient and then you add time to make sure all the scans are at the central imaging lab. It takes time because we want the radiologist to look at all the scans of each patient and then they’ll do some analysis by specialized vendors. And they’ll get presented to an expert panel. And the expert panel has the right to go and audit some of the data. They can review the scans themselves. So you have to allow time for that where they can go look at the scans if they want to Q the interpretations, etc. And once they've done all that then they write their own brief report indicating whether or not they’ve met the per the pre-specified per protocol criteria for a successful study. So all that takes time.