What! Of course I'm rooting for an early halt...but if not, I'm not going to lose sleep over it.
BTW, an interesting observation to all... Marucci was quick to jump in and piggyback onto Davis' response by focusing (almost to the point of nauseation) on the "historical" P-values reached in previous trials. Found his intense recitation (with great precision) on the "history" of P values somewhat peculiar...perhaps I'm reading too much between the lines, but maybe an optimistic sign.
IMO, whether we hit the pre-designated P-value now to warrant an early halt; or whether the trial needs to run it's course really makes no difference to a long term investor. Data read out across all previous GBM-vIII trials (both in frontline and recurrent patients) has already "overwhelmingly" demonstrated Rindo's efficacy to sustain approval. Now it's just a matter of time to reach trial design benchmarks. With every "Event" we get closer to that needed P-value. Basically, the conference call reaffirmed what many long term investors and institutions already know.... it's no longer a matter of "if" just "when."
Definitely a solid presentation! Commentator was articulate and surgical with his questions, and Marucci and Davis were impressively spot-on with their responses. Both were forthright, detailed, concise and sounded exceptionally comfortable and confident. I was very pleased on how Marucci was quick to jump in after Davis' responses with additional highlights to questions, to include big-picture development plans down the road. All in all, very impressed and IMO confirms why CLDX is rated as a "strong buy" by analysts industry-wide. The presentation webcast is available on the "Events & Presentations" page of the "Investors & Media" section of the Celldex website.
Thanks for your data timeline analysis. Your use of a median OS of 15.2 months among EGFRvIII glioblastoma patients seems reasonable (and even more optimistic) than the14.07 median OS reported in the following NCBI published abstract... “The natural history of EGFR and EGFRvIII in glioblastoma patients” published on Oct 19, 2005. This study focused on patients across 3 groups (no EGFR expression, over expressed EGFR only, or EGFRvIII) following operative radiation and chemotherapy treatment.
Per abstract,... “The median overall survival times for patients with tumors having no EGFR expression, over expressed EGFR only, or EGFRvIII were 12.3 (95% CI, 8.04–16.56), 11.03 (95% CI, 10.18–11.89) and 14.07 (95% CI, 7.39–20.74) months, respectively, log rank test p 0.05).”
Whip... never said you made up the "fireside chat" and I was already fully aware of the PR's use of this expression. No offense intended. However, you got to admit that the whole "body language" and "fireside chat" visualization with Marucci and Davis is a bit humorous.
Yup...we're nearing the end of the "final" shake out and then the "manipulated" move up (like the old days). Still accumulating on the dips.
Body Language Reading and Fire Side Chats? This is a HC Conference? ...and not some sort of Kumbayah campfire festival? Analyzing Marucci's and Davis' body language? Rats, and I'm gonna miss it! In all sincerity, you made me smile today. Thanks :)
topper4 writes..."greater minds say otherwise. The market is not stupid."
Are you familiar with MM manipulation and naked shorting? Unprecedented disconnect exists between current stock price and asset value of CLDX's current pipeline and IP. Share price does not reflect potential success of Rintega ...rather, just pure manipulation and shake-out for shares.
If not today, IMO definitely before the weekend. It was agonizing watching today's trading...definitely getting harder to buy up shares in low $7 range.
flagslap, If you went to business school you'd know that one of the many objectives of "Advertising" is to generate product "awareness." When talking to my many diabetic friends at work, church, neighborhood, etc... only about 1 out of 10 have ever heard of Afrezza. IMO, Sanofi purposefully prolonged their DTC campaign giving some phony, concocted excuse that advertising had to first start with physician awareness before an aggressive Direct to Consumer campaign could ensue. Sanofi knew they were dealing with a paradigm shifting therapy and should have known better by pricing Afrezza more competitively and rolling out both marketing strategies with equal emphasis.
Mini Mannkind Company..."Alfred Mann is licensing out his Technology Platform to a company that he could eventually buy back or he could sell Mannkind Corp too."
Yes, a possibility; however, IMO time is of the essence as MNKD's cash reserves are a major concern (good for approx. 6 months); and more than likely, MNKD's proposed Afrezza marketing strategy will not realize sales efficiencies quick enough to keep pace with cash burn. A situation that's further complicated by MNKD not acquiring 100% Afrezza commercialization rights back from Sanofi until April '16. I believe MNKD will need a cash infusion in the near term to keep it as a viable operating concern. Hopefully, the MNKD-RLS licensing deal includes an upfront cash payment or MNKD negotiates some other financing deal that doesn't require stock dilution. Perhaps a reverse merger with RLS.
ooo_key_doke....Be sure to remember points #4, #8 and #9 when you say good bye to a son or daughter when commandeered (drafted) for the next World War. The phrase "Perfect Storm" comes to mind. If I thought any substantive, intelligent dialogue would work, I'd respond in greater detail. However, since not, have a nice day.
Disagree with your pps valuation based purely upon cash only. IMO, it's cash "plus" perceived value of pipeline by Big Pharma ....who have tons of money waiting on the sidelines to soar in and easily (and cheaply) add to their pipelines. After this biotech meltdown, we're in for considerable M&A across the sector. Worst case, CLDX gets bought up for a price double, if not triple, today's pps value. If one can afford to wait it out, it's certainly not a bad place to keep some money parked... and a win-win scenario IMO. Continuing to slowly accumulate on the huge dips. Good luck to all.
Spot on! Exactly why I'm slowing accumulating. Moreover, everyone seems to have forgotten about Varli's value to the pipeline, even should Rintega encounter a few hurdles in the short-term with the FDA. Don't be spooked.
cyoung, While I like Kasich too for reasons you cite, the Donald scored a lot of points with me tonight during his interview with Bill O’Reilly. IMO, the Donald was spot on by pointing out that the media makes millions from these circus act debates; and after having participated in six of them, it begins to smack of manipulation and self-serving motives and is less about productive, information exchange. He emphasized that his decision to not participate in tomorrow night’s debate, has everything to do about personal character and sticking to one’s guns when enough is enough. A character trait that the American people can expect from his Presidency when negotiating with China, Russia and others who attempt to manipulate and capitalize upon America’s goodwill and "excessive" practice of “forgiveness and turning the other cheek.” Playing on his terms, the Donald has chosen to better spend his time raising funds for Veterans in lieu of participating in tomorrow night’s stage show…despite a possible hit in his polls. IMO, an honorable and respectable response.
"All they need is to convince someone with a deep pocket to dish out $1-2 billion for the launch."
Yes, and it may be Receptor Life Sciences via a "reverse merger" deal ...assuming RLS is backed by venture capitalists with deep pockets.
Disagree. IMO, Al Mann's reputation, personal financial backing, and investment connections gives immense "added" credibility for success in an otherwise high risk, high failure investment sector (Biotech) ...and are among the many reasons I remain long in MNKD.
Mike writes ... "It really is beyond belief that this incessant BS goes on and on---when will it ever end?"
IMO, as long as Big Pharma controls and manipulates everything, the Afrezza and the TS platform will never get a fair shake or gain traction unless MNKD thinks outside the box and explores venture capitalist deals. As a new, paradigm shifting technology that threatens (head-on) current multi-billion$ drug delivery platforms, be assured that Big Pharma will continue to obstruct and the BS will continue, and more than likely become worse. IMO, MNKD (and Al Mann) tried playing by the BP rules (in good faith) and they got snookered by Sanofi (AKA Sanosaurus). Personally, I could give a hoot who RLS is and they can remain anonymous for eternity, if they so desire ... as long as they can come up with the money.