See the FDA document dated April 23, 2014 - interesting read:
"Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions - Draft Guidance for Industry and Food and Drug Administration"
To the best of my knowledge, this draft guidance has been issued only for public review and commentary...but is as yet unadopted. My opinion is simply that a balanced measure of expedited access will be struck based upon observed and measurable mechanisms of rehabilitative response and expert perceptions of mitigating unmet patient need in both categories of ASI and CSI.
Garo seems to be a "close to the vest" player....undisclosed partnered studies, unknown royalty structures, and under-announced milestone payments. Any chance we're looking at an offering here at $4 anytime soon?
Rational commentary invited...
Please tell me these guys didn't take it this far just to give it away...
Having spent some time looking for partnering conditions, milestones, royalties, etc... I found this comment in today's Boston Globe:
"Shares of Agenus Inc. jumped on news that a test run by partner GlaxoSmithKline for a vaccine that relies on a molecule developed at the Lexington firm has ended in success, not only for potential shingles sufferers but for those with other diseases. Glaxo said a trial of its experimental drug greatly reduced chances of getting the common, virus-borne disease among patients enrolled in the trial. If the drug is approved, Agenus would get an undisclosed percentage of royalties. Agenus’s molecule makes the vaccine more powerful."
Anyone know if a milestone payment is attached to P3 success, NDA submission, or FDA approval?
Any clues as to royalties anticipated?
Thanks in advance...
I knew you couldn't possibly resist commentary such as this...
Merry Christmas, drizzle britches...
Franca, see the document:
"Guidance for Industry: Expedited Programs for Serious Conditions – Drugs and Biologics" published as an update May 2014... There are special considerations that apply to accelerated approval, and data suggests BRAFi monotherapy w/ Vemurafenib has enabled a less effective follow-up when followed by combo V&C (the combination is actually less effective in the wake of prior BRAFi treatment.) I think there may be a shot at early approval with a rolling review, and Roche has experience with this type of filing. I expect the NCCN will soon address this issue, and an ADCOM would likely result to work through the details of the complicated rolling review process. Keep up the good work...
..."you rescuing horses again..??"
My wife still networks to re-home equines at risk of slaughter. I've discouraged her from personally keeping anymore for a spell. We've currently got 10, 6 of which are rideable. It leaves us a lot of chores, and I'm a bit challenged when the days are winter-shortened. This past year, my wife and I have rehabbed and re homed 8 others, and I'm more comfortable time-wise with the smaller herd. Everybody gets more attention. Feed bills are easier to manage. We'll see how long that lasts... Merry Christmas to you, Joe...
Dontchya'll go gettin' all drama queen, sunshine meth-head gummy-bear goo-goo dolls and tweaker lollipops crazy on me...It's simply "holidays going on" and ol' franca_ole is posting updates regularly - Good job - by the way...
Lotsa good research going on for those willing to look, and the future of cMET inhibition is continually being highlighted by new trials being fronted by OPM. My optimism for Cabo remains, I feel cobimetinib value exploration is in its infancy, and I wish the best for all in 2015. Have a Happy...
...seems to be getting a bit edgy, and I clearly see it as a "tell".... He's become a nervous Nellie.
Every EXEL poster posting positivity - day or night...rain or shine...up-market or down...
Has been parlayed by Seymourjiznu with derision...zero shareholder equity...
Baghdad Bob...carnival barkers....longs aren't as cool as me...
Blah, blah, blah...
Get ready to grab yer ankles and smile, dooshwaddle...
Yonder comes Big Papa...
Offsite, you crack me up...how many aliases do you work?
1 post | Last Activity: 37 minutes ago
Member since: Nov 29, 2014"
If you actually believe it takes courage to tolerate the likes of yourself...
...you truly are one very misguided, misbegotten twit...
"The question is what exel will do if it succeeds in pain and bone responses?
What if OS is statsig in COMET-2?"
Controversy, debate, and expert testimony possibly resulting in ADCOM.
Everybody have a great holiday!
"...does EXEL get any payment from Merck ?"
If they do, it'd be a pretty neat trick.
In developing cobimetinib, EXEL is partnered with Roche...
Initial documentation of patient progress via application of the Abbreviated Injury Scale should take place on or about 1/15/15, and each 3 months thereafter. Without an associated comparator, I'd expect expert analysis of clinical perception to determine treatment viability. Even if the news proves great for Jarrod, I wouldn't expect much real information to be released pending presentation at a future neurologic venue. Clinical protocol and patient privacy rights will take priority over shareholders in the near term. Patience will be required with these early interventions as trial protocols may need be amended, and peer review of trial analytics will be an important factor in determining the most appropriate pathway forward. GLTA
I wanna be Martini...and if you say I can't...
I'm done. Puh-leeze lemme be the Man...
"So, are you proposing the secondary endpoints of Comet-1 and Comet-2 could qualify for a PIII?"
Not at all...but I am suggesting that the aggregate of all mCRPC data will adequately define a Cabo-sensitive patient group that will inform a trial designed toward validating Cabo's efficacy within a defined subset. Duckduffer had mentioned this in an earlier post, and he and I are in agreement that a likely target population might be the one which responds well in the initial 12 weeks of Cabo therapy, utilizing therapeutic response to Cabo in terms of optimum BSR, concurrent pain relief, CTC reduction greater than 50%, bone turnover markers, and therapeutically responsive hemoglobin and LDH levels.
Differentiating the responsive group from the non-responsive group would be key to determining EXACTLY which patients constitute your target group for Cabo. "High grade" the patient pool - so to speak...
Easier said than done, but such patient definition would inform a trial virtually guaranteed to succeed, albeit in a smaller, less commercially viable patient pop... I feel this is an inevitable culmination to these lines of research - defining a trial group targeting a hazard ratio closer to .6 than .9. Statsig OS achieved based upon early response to Cabo therapy, while admitting that there will be patients that Cabo can not hope to help.
The abstract is available in entirety at the ECCOdotorgdoteu website. No biggie, as it is a Roche preclinical work up. I mention it specifically to elucidate Cobi potential beyond what is known currently. I see compatibility with ERK inhibition as very positive.
"Conclusions: The robust and dynamic nature of MAPK signaling, particularly in the context of therapeutic intervention, helps to explain the limited clinical success observed with single agent MAPK-targeting strategies tested to date. Our results elucidate a highly effective strategy that combines MEK and ERK inhibitors to more significantly suppress the MAPK pathway. These results add to the fundamental understanding of how the MAPK pathway mediates oncogenic signaling and offers a new combination approach to target MAPK dysregulated tumors."
"The one that ulingt pointed out is specifically for bone. Comet-1 and Comet-2 were neither for bone. It's a different study altogether..."
We'll have to agree to disagree here. Bone scan response and interpretation are secondary response measures in both Comet trials. As far as the UMCC P2 study being bone specific...sure, but still bone specific in mCRPC. What you are neglecting to see is that the aggregate of trial analysis is attempting to tie BSR, pain relief, and biomarker assay to reliably predictive OS. Biomarker guidance will prove key to any future success for Cabo in mCRPC , or - IMO - it will become another missed opportunity, subject to the prescription whims of evidence-based oncology, as opposed to becoming part of the SOC treatment algorithm.
Ulingt, my apologies for the earlier incomplete response. I got distracted. I hope you had the opportunity to check out the Dave Smith UMCC abstract. There's a lot of good info there, and I suspect secondary outcome reporting will be favorable as well. MMM has said many times that the regulatory path forward is unclear for Cabo in mCRPC, and also that the aggregate of evidence from the Comet trials will be critical to determining the future use of Cabo in that indication. No one knows (not even semanresu) how that will play out, but let me suggest this to you for your consideration:
Cabo has displayed a clear, undeniable history of therapeutic benefit in managing mCRPC. Whatever the reason for Comet-1 failure to display statsig OS, the resultant survival benefit still favored the Cabo treatment arm in that trial (HR less than "1"). Despite favorable primary endpoint results from the UMCC P2 trial, I don't expect another such relevant P3 trial will be pursued. Rather, I expect that the mature Comet data will be pooled and screened for clues to identify Cabo's most responsive patient group. All the biomarker data being generated by the CRADA/CTEP/NCI/IST partnerings will be utilized to this end...including SU2C, PCF, and patient-generated data wrt hrQOL related benefit. JMO, but no clearly-defined Cabo-sensitive patient group = no regulatory path forward in mCRPC. The aggregate of peer-reviewed data will be fully utilized, and no stone will be left unturned. That said, I don't expect to see an sNDA filing for Cabo in mCRPC anytime soon - regardless of Comet-2 results. If the aggregate of data remains favorable, I DO expect to see the NCCN make some future determinations of Cabo use in the prostate space based upon ongoing clinical perception, clear evidence of benefit, and the emergence of a biomarker-defined Cabo sensitive patient population.
This study met its primary endpoint and published (minus presentation at ASCO 2014.
2014 ASCO Annual Meeting I encourage you to visit it in the ASCO library.