It is nice to hear that spin-artists have something positive to say. At least, they do not think ARQL will go bankrupt this coming Monday. Very hopeful!
ARQL has screwed up MARQUEE big time. They never have done c-MET pts testing and evaluation (remember Roche enrolls only c-MET+ pts for their trials. Roche has learned from their NSCLC Ph2 trial failure for general ITT population.
Where are we going from now? The company
* Is in a state of panic. The management do not market either company or its products/prospectives too well.
* Jap partners have very little if any experience of running oncology trials
* Market Cap is at their cash value. Nobody expects any good news from ARQL
* Previous trials (assuming ARQL did not lie) have shown that Tiva has shown highly efficacy in NSCLC and 2nd-line HCC. If it is a case, wrong pts were selected for MARQUEE. Remember C-MET is a targeted therapy. It is not for every single cancer patient.
* Accordingly to ARQL,
- They are evaluating ways of how to stop MARQUEE, evaluate its results, and see what they have in NSCLC. NSCLC Ph2 in KRAS-mutant pts is still going with NO plans to shut it down (FDA would not like it).
- MARQUEE results are coming
- HCC Ph3 trial will start soon
- mCRC Ph2 results will be available soon
The bottom line
Nobody expects any good news from ARQL but the results from MARQUEE (one can look at the trial as a large Ph2 with tons of info) and Ph2 mCRC are coming.
If any of these results are good then either ARQL goes back to $5-8 by Apr-May 2013 or will be bought out above $10.
If the coming results will be poor, ARQL will be a dead-investment for the next 2-3 years.
Finally, Ph 1 & 2 are exploratory clinical trials. There is no need to have double-blind Ph 1&2 when the results are unknown for a long time and researchers have no flexibility to evaluate and change/modify these trials as they go.
CRC results ABSOLUTELY critical. Going in ph3 HCC doesn't really matter...we know that's going to happen but we're faced then with 2 or 3 year wait....so CRC is only thing that can help now...and I've no idea what our chances are. 9 patients in ph 1 doesn't really provide any visibility. As for pipeline, braf and 621 (or whatever it is), my guess is they're on the shelf collecting dust. I'm disappointed with the situation but those last secondary buyers...they've got to be " really disappointed"...they got zyngad!
Take my word MARQUEE results for c-MET+ 2nd-line patients will be very good. Why?
- Pucci mentioned that PFS was very good but mOS was very poor
- Pucci also said that 200+ patients were still alive and getting Tiva. Remember that the previous Tiva Ph2 in NSCLC and historical NSCLC indicate that these 2nd-line NSCLC patients have PFS `2 months and OS~7 months. This means that 40% of MARQUEE patients who got Tiva are alive & well and their disease did not progress after more than 8+ months after getting the Tiva treatment. Again, most of these patients supposed to be dead by now but they are still alive without disease progression. So, these patients will be alive for ~12 months. This is what the best NSCLC drugs can do for the 1st-line patients.
Tiva works in NSCLC for c-MET+ patients. MARQUEE trial was poorly designed targeting the wrong patient population. However, there are plenty of c-MET+ patients to show and to prove the Tiva efficacy in this NSCLC subgroup.