Replies to post #2674 on Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

“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.

It's now been 3 months since 6-month data was available. Yes, they need to do all the stuff quoted above but a bunch of this stuff they have to do is/should be done concurrently as the data comes in; for example, reading the scans and making sure the scans are at the central imaging lab. Here’s a apropos quote from NWBOs description of what it entails from a Feb 2019 meeting

In order to do the final data collection a CRA Clinical Research Associate, employed by the independent CRO, the organization who is managing the trial independently, has to physically go to the sites, sit down with the trial database and the hospital records and compare them and find any piece of data that's missing or there's a discrepancy. The way the data gets captured in a clinical trial is in what's called a case report form. A case report form can be a hundred pages long. And you're looking for any piece of data that's either missing or there's a discrepancy. At every one of these [X] sites for every one of these [XYZ] patients. And each one where there's a piece of data missing of there's a discrepancy, generates a query. And a query has to be resolved and the resolution has to be validated…

Did the CRA wait till after 6-month data has accumulated to do all this stuff. I don’t think so. The longer this takes to release TLD, the more naysayers will be playing w people's minds.