Yes, it is encouraging. Since it was 6-18 vote, the majority out of six means at best five supporting votes, apparently from urologists.
I am not trying to change your opinion. Why would I do that? But you brought this case here and I looked into the data. I am sure that Spectrum will also have difficult time during Adcom meeting. I am not excluding similar scenario, since even after FDA agreed to combine two studies in one, not all members of the committee will accept it, especially members which are familiar with statistics. BTW, even after negative vote, MCNA could be approved as scheduled. FDA may not follow ODAC's recommendation regarding the NDA.
I think, it is an example of how FDA treats studies which failed to achieve primary endpoints.
From FDA Briefing Document: "The primary efficacy objective was to demonstrate that a 1-year disease-free survival rate (DFS 1y) was not lower than 40% based on Kaplan-Meier estimate. However, the Applicant reported a DFS 1y of 25.0% in MCNA-treated subjects."
"However, in light of the limited treatment options for patients with BCG-refractory NMIBC, FDA views the trial results, especially the results in the subpopulation of subjects with CIS-containing disease, worth consideration in an advisory committee meeting."
It all sounds familiar.
"There was significant good news this week. Thursday we awoke to learn that the company had submitted plans for Phase 2 trials on Poziotinib."
Submitting plans is barely a good news. It is neutral news. Therefore, no stock price reaction to it. Real good news would be positive results from phase 3 or even phase 2 trial or NDA approval.
With zero spending, all updates on Trial site worth nothing. Trials cost money.
"Do you not think 1620 is dead?"
Best evidence that SPI-1620 is dead is that there was no spending associated with both trials in the last three years. Although some other forgotten drugs like lucanthone or renazorb deserved spending. Check their 10-K report.
"We got 20% of CASI with a mkt cap of ~ 38M plus a 1.5M promissory note to sell Zev, Marqibo, and Evomela in China so assuming one third of this is a result of Zevalin that’s another 13M."
Bad math. It is 20% of $38M market cap which is equal to $7.6M divided by 3, that gives $2.5M. Plus $1.5M promissory note divided by 3.
But your forgot that revenue from Zevalin sales in Europe and Pacific Asia in four years was $36M. How much of it is profit is anybody's guess.
Last year, Spectrum received $5.2 million from sales of Zevalin in Asia Pacific region. Therefore, they sold it to Mundipharma for 5-year revenue stream. Not bad. However, it also means a decrease in Spectrum's revenue by $5.2 million/year starting from next year.
Who is next in the race?
Not sure, why did you bring it here. In a described phase 3 study, Folotyn was not used in combination with Romidepsin (Istodax). Each comparator was used as a single agent. Point is that, Alisertib, is not better than Folotyn or Istodax. It is worse, actually.
From recent 10-Q:
In September 2015, Servier notified XOMA of its intention to terminate the Amended and Restated Collaboration and License Agreement dated February 14, 2012, as later amended on November 4, 2014 and January 9, 2015 (the “Collaboration Agreement”), and return the gevokizumab rights to XOMA. Termination of the Collaboration Agreement will be effective on March 25, 2016.
In 3dQ results PR, XOMA stated: Terminated the Phase 3 EYEGUARD clinical program and associated expenses and regained global rights to the gevokizumab program. Does regaining global rights mean that Servier is out?
3984 The Survival Outcome of the Patients with Relapsed/Refractory PTCL-NOS and AITL
Interesting and important observation:
"Use of pralatrexate or romidepsin at the 1st or after 2nd salvage therapy were not associated with longer PFS2 or PFS3, but, the patients who received pralatrexate at some point during therapy had significantly longer OS than who did not in patients with PTCL-NOS (median OS2: 8.5 vs 31.1 months)"
From this abstract you could learn about survival benefits from front-line chemotherapy (PFS1 and OS1), first salvage therapy (PFS2 and OSP2) and second salvage therapy (PFS3 and OS3).
To remind you, pralatrexate is Folotyn.
Abstract 341 "First Multicenter, Randomized Phase 3 Study in Patients (Pts) with Relapsed/Refractory (R/R) Peripheral T-Cell Lymphoma (PTCL): Alisertib (MLN8237) Versus Investigator's Choice (Lumiere trial; NCT01482962)"
And investigators chose Folotyn, Istodax and Gemcitabine as comparators.
And conclusion is "While alisertib showed activity in R/R PTCL, there was no significant efficacy benefit vs comparator."
It is an informative abstract where you can find efficacy data (ORR, CR, PR, PFS) for Folotyn and Istodax obtained in the same phase 3 study.
Too many studies. Depends on disease subtype, stage, age, etc. Quick search gave me 61% CR in one 318-patient study and 64% CR in another 199-patient study.
It is combination of Belinostat and CHOP in front-line PTCL. You don't know the contribution from Belinostat in this regimen. Spectrum is going to study this combination against CHOP in Phase 3 trial.