You're exactly right. I noticed this presentation at ASCO as well.
Let's preface with the reality the typical small cap biotech on the NAS can in-license a drug, run it through preclinical, and get it into Phase 1 clinical trials in 3-6 months on the average. PMCB has been recycling the idea a clinical trial was just around the corner since 2014. Or that an IND would be ready by EOY 2016. Then there was there some raw meat thrown out by Kenny hinting end of Q1 2018, and if that didn't happen then... whenever. Two yrs ago I gave this scam a 50:50 chance it would be in a Phase 1 CT, unable to recruit patients - open recruiting forever as the status. Kenny doesn't need an IND approved in order to collect his $375K salary, plus stock options adding up to $1M/yr. Neither do the other board members.
One can provide a link giving an ORR of 70% for tumor reduction of 30% for Adding cisplatin to the standard gemcitabine/nab-paclitaxel drug treatment. And the responses are the Kenny line: Unmet need, nothing out there to shrink tumors.
One can cite:
Then there is the Phase 1-2 study involving a CTGF Ab due to be completed in Dec 2018. Top line data presented in Jun showed 70% shrinkage.
Once again the response is the Kenny line: unmet need, nuttin out there to shrink tumors. As the anti-CTGF proceeds to Phase 3, it's likely to generate another CT using radiation/surgery. Maybe throw in a PDL-1 inhibitor to help the CTGF to shrink the tumors more. Meanwhile Kenny collects his salary, and that IND is just around the corner.
There are two reasons 2 reasons why all of a sudden the Kenny gang has retreated from using 5-FU as the comparative arm:
1. PMCB's $1M cash on the books (ref: 10K) does make a gemcitabine/nab-paclitaxel comparison too expensive. And since it's about resulting tumor size, throw in the cisplatin. Note the SG&A vs research expenses. Where the later is likely being gobbled up by accounting tricks for the paid consultants.
2. The FDA doesn't allow trials where the comparative drug is likely to fail before the CT is over, resulting in high mortality. They insist on better for comparison. The FDA probably gave the Kenny gang a big hint, their proposed 5-FU arm was DOA.
There is nothing in the literature that suggests metronomic chemo with alkylating agents are useful as a radiation sensitizer. What's that we have the magic CIAB beads? True, but without a control arm of Metronomic Ifosfamide alone, no conclusions can be made as to the effect of the beads. The FDA is likely to remind the Kenny gang.
The so called unmet need of shrinking, and removing the primary PC tumor is likely to be met, long before the Kenny gang gets their mythical IND in, and approved. The only interesting question is the continued appetite by retail for this scam. In the last yr 100M shares were issued bringing the O/S up to 1B, with the A/S set to allow another 400M. Most of the new NAS small caps have an O/S under 50M. Microcrap scams like PMCB are always in the hundreds of millions, or even a billion+ shares.
As cleanup there was some post response about comparing ARMO facilities bought by Lilly to PMCB facilities? PMCB has no facilities. And Lilly was interested in buying the drug, not the buildings.
The Jewel of the Mind is Colored with the Hue of what it Imagines