Beat me to it Whip. That's about $300k he has spent the last 2 weeks. Good sign.
Point taken. Explain the large director sale on 6/12/15? About 220k shares?
I generally agree with your post Whipper but you have no clue or right to ask a person to invest in a firm. Insider buys, while nice, are not an indication of future performance, I once owned a Bio called Astex Pharma(ASTX) where people always complained if no insider trades. Guess what, they were talking to outside investors for 1.5 years before selling the firm for $8.50 per share. Mgmt's options were given at $3.76. Recently Receptos was sold to Celgene at $232 per share. Those negotiations were ongoing for a year. Guess what, the SVP/General Counsel sold shares on May 5th 2015 at $154 per share. They were in the MIDDLE of NEGOTIATIONS with Celgene. Who in their minds would leave money on the table? He knew they were about to be sold!!!! Bottomline, don't assume logical when dealing with Insider sales/buys.
There was widespread optimism that the FDA would allow CLDX to file a BLA in second line glioma patients based on the small but randomized phase 2 ReAct dataset presented at ASCO. The company never promised more than entering discussions with the agency, but with the compelling data showing a clear survival advantage, widely reported in the national press, and the urgent unmet need, I certainly expected a filing this year.
FDA would not allow them to file, saying that the dataset of under 100 patients might be too small. Goes to show that "Breakthrough Designation" doesn't mean as much as we thought.
The analyst community was clearly surprised, as the aftermarket trading shows.
The company will need to get the complete data from the phase 3 ACT 4 study first. The next interim look at that trial comes around yearend, maybe q1 2016. The hazard ratio required to end the trial on this look is .65, and by all indications (including 4 earlier trials), there's a good chance of success. So most likely, today's news is on;y an 8 month setback of the timeline on the company's lead product.
The rest of the story remains the same. The company has plenty of cash and 5 other products in at least a dozen different company sponsored trials, plus a couple of investigator sponsored studies.
Upcoming catalysts are:
The SNO meeting, early November. This will be data on long term survival of Rintega patients. The product has been in trials for over a decade, and about 15% of the folks that respond to the vaccine are very long term survivors. Some of the first patients to get the treatment are alive at over 11 years. This data should be good and raise expectations again for the outcome of ACT 4.
The second interim look at ACT 4. probably next January, give or take a month.
Next years ASCO meeting should feature the first data from combination studies of Varli and other agents . Most importantly, the data from the combination of BMY's PD-1 mab, currently the world's highest profile cancer drug, and Varli, will be very highly anticipated.
Today really sucked, but doesn't change the long term story at all.
U funny Long. Thanks again for all the great info you provide as a "small retail investor" :) Max
As usual Long, Thanks. Can I ask what your background is? Are you a medical researcher? TY, Max
Dr. Readon called the results "historic".