"We met with the FDA. Based on our discussions with the FDA, we're starting another study, a Phase III study. That study is with the FDA right now. We'll shortly hear back from them. And in addition to that, we intend to file the new drug application. So that's where we are with apaziquone."
Two years passed. Why it is so difficult to start a study?
XOMA is going to partner XmetA and XmetS. Could be a substantial upfront payment.
"If it does better with PFS but not OS, I would worry about resistance"
OS data will be difficult to interpret due to crossover. All patients have the option of receiving selumetinib with or without dacarbazine at disease progression.
"As for Binimetinib, people seem to be more positive."
One reason to be positive about Bini+Enco in Braf-melanoma is that one combo of Braf+MEK inhibitors is already approved by FDA (GSK-Novartis) and another is pending approval (Roche).
"I search the clinical trials page"
Try MEK 162
Phase 2 data are solid with two-fold increase in PFS in selumetinib arm as compared with temozolomide arm. OS benefit was not clear. SUMIT trial has a different design comparing selumetinib plus dacarbazine with dacarbazine alone. Selumetinib is clearly active in uveal melanoma. There are good chances for significant increase in PFS in SEL+DAC arm which is primary endpoint of the trial. Not sure about OS though.
"The Company’s Board of Directors, including the Compensation Committee, acknowledges the advisory vote on executive compensation and is committed to making meaningful changes to executive compensation and related disclosures in consultation with compensation experts. In the past year several changes were made. Two new members were appointed to the Compensation Committee, a new chairman was appointed and the Compensation Committee Charter was revised. The Compensation Committee also retained an independent
compensation consultancy, Exequity, to conduct a competitive review of the Company’s executive compensation program. As a result, in 2014, although product revenue increased by approximately 31%, the Company’s Chief Executive Officer’s realized pay decreased by approximately 34%. In order to better align executive pay with stockholder returns, 75% of the Company’s Chief Executive Officer’s pay is at risk (annual
cash bonuses, restricted stock awards and stock option awards) with a base salary that represents only 19% of total compensation. The Board of Directors and management look forward to continuing a constructive dialogue with stockholders in the coming months."
Proposal No. 2 :
The Company’s stockholders approved the flexible settlement feature in connection with the potential conversion of the Company’s Convertible Senior Notes.
Proposal No. 4 :
The Company’s stockholders did not approve by advisory vote the executive compensation detailed in the proxy statement.
"In a comparison to other MEK inhibitors tested in RCC reviewed in the paper mentioned above, these results are much better than those obtained for other similar compounds."
The author thinks that Cabo is a MEK inhibitor. Big news.
Chances are low. Do not compare CE-Melphalan and Beleodaq approval processes. Beleodaq was granted a priority review meaning that FDA's goal is to take action on an application within 6 months. CE-Melphalan does not have it.
at 3d Anticancer Agent Development Congress on May 18, 2015 in Turkey.
Presentation "Apaziquone (EO9) From Concept to Clinic; Lessons to Be Learnt" was made by Qasem Abdallah (SAUDI ARABIA). Who is this guy?
BTW, it was under SESSION 1: NATURAL COMPOUNDS WITH ANTICANCER ACTIVITY. I did not know that Apaziquone is a natural compound.
"performance bonuses are more contingent on Apaz and SPI-2012 movement"
In this company, performance bonuses will be issued anyway. No matter what happens with performance and results.
What is so magic about $100M in cash by the end of 2015? It is just a number. Where is the logic? What is better, to have $100M by doing nothing and receiving performance bonuses or to speed up SPI-2012 and Apaziquone developments but having $60-$80M by the end of the year?