Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Muchogusto, I am just trying to make a reasonable assessment of the facts. Like everybody else, I was thrilled by the quick recruiting of the MDA and SPPI trials...in the US, and thinking, if MDA recruited their 50 relapsed EGFR pts at one site in a year, SPPI can recruit their (less than) 87 pts at 40 something sites in a timeframe similar to that. Considering that SPPI 1st dosed patient was on Oct 13, 2017, it would be reasonable to think the last pt dosed would be around the end of the year (plus or minus a couple of months). Let’s ignore the EU pts for now. SPPIs Primary endpoint is:

1. Objective Response Rate (ORR) [ Time Frame: 24 months ]
The proportion of subjects who achieve Complete Response (CR) and Partial Response (PR) by the best response from the first dose of poziotinib to the end of study.

I am out of my league here, but do we have to wait till 24 months after the last patient is dosed before the data is mature enough to submit for approval? I don’t think so. They will be able to determine if a pt has a confirmed ORR after the second scan at 2 months. Let’s say they then submit a NDA after they scrubbed the data, and we are talking end of 1st Q 2019. Assuming they have Fast Track (and BTD) that would take 7 months from when application was submitted to approval and pozi would be approved before the end of 2019.

Do we have to wait for the secondary endpoints?

Secondary Outcome Measures :
1. Disease Control Rate (DCR) [ Time Frame: 24 months ]
The proportion of subjects who achieve CR, PR, and Stable Disease (SD) by the best response from the first dose of poziotinib to the end of study.
2. Duration of Response (DoR) [ Time Frame: 24 months ]
Number of days from the date that measurement criteria are first met for CR or PR (whichever status is recorded first) until the first subsequent date that progressive disease or death is documented.
Other Outcome Measures:
1. Progression-free Survival (PFS) - Exploratory [ Time Frame: 24 months ]Number of days from the treatment start date to the date of documented disease progression or death due to any cause.

If we have to wait for the DoR (Time from documentation of tumor response to disease progression), instead of ORR confirmation at 2m, we’d have to wait another ~6-12 months?? since I assume this is a median value. If this is the case, that takes to the 2nd- 3rd Q 2019. So let’s say August 2019 plus 7 months takes towards the end of the 1st Q 2020. Can they get approval based on ORR and then update the label based on secondary endpoints. I dunno.

Now regarding the EU pts, do we have to wait for them to be recruited and EU patient data mature before we can submit the application? Right now I’d have to say yes. JT talks about his trial being an international study so the EU pts are part of the cohort (ITT) so I don’t see how you can exclude these patients. And, as of now, they haven’t recruited any. And how many do they need to recruit? Say they started recruiting today, how long before they have all the patients they need? 9m? a year? You would have to add that to the timeline.

I am hoping that they give up on initial EU recruitment by amending the protocol to be just a US trial and get pozi approved towards the end of 2019 to the end of 2020 timeframe and in the meantime start an EU trial. This is IMHO. I am not a clinical scientist, I am just an investor like everyone else. And w regards to ‘is this effecting the stock price’, I dunno, but you know that the big boys have their own PhDs and specialists out there who know exactly what’s going on. If we have to wait for the EU pts, that takes us into a 2021-2022 timeframe. That's why I would love (crave) to have more regulatory clarity, and ps, when I talk about executing, the EU recruitment is one of the things I think of that they need to execute on.

Now back to the kitchen project.