The decision to discontinue the trial shows that the investigation revealed that the treatment protocol was followed and confirms the IDMC finding of futility. YOU inserted the word "investigating" into your misquote from the PR.
"Finally, the DMC requests that Galena Biopharma inform the IDMC members of the outcome of this investigation*** and any decision with respect to discontinuation of the clinical trial*** as soon as possible"
June 29 Galena issued press release:
Galena Biopharma*** Discontinues**** NeuVax™ (nelipepimut-S) Phase 3, PRESENT Interim Analysis based on Independent Data Monitoring Committee Recommendation
Looks like the investigation and decision to discontinue occured "as soon as possible".
12.3. Termination for Commercialization Concerns.
(a) If at any time during the Term either Party has a good faith concern that the***** safety profile of the Initial Product adversely affects its commercial potential or does not warrant further Commercialization**** such Party shall notify the other Party of such first Party’s concern and the Parties shall promptly discuss such concern in good faith.
No, the accuracy of data submitted following the 70th event is not being questioned. Systemic reversal refers to a change in recurrence results in the arms since the 70th event. Pretty remote chance Neuvax suddenly became effective.
Trovagene, Illumina Reach Technology Assessment Deal
All results from its agreement with Illumina will be shared between the parties, and the deal, which was reached on June 20, will terminate either 30 days after the completion of the evaluation of the technologies, or on the one-year anniversary of the agreement, whichever comes first, unless extended by mutual agreement.~ June 25 2013 Where is revenue resulting from this agreement?
Trovagene, PerkinElmer Ink Assay Development Deal Targeting Liver Cancer
Under the terms of the deal, PerkinElmer will pay Trovagene milestone payments. PerkinElmer also has received an exclusive option to obtain a royalty-bearing license to use Trovagene's technology within the area of hepatocelluar carcinoma, as well as an exclusive option to obtain a royalty-bearing license to use Trovagene's technology in fields other than hepatocellular carcinoma.~ April 26 2016 ~ Shortly after this agreement Perkin Elmer sent TROV a check for around $100,000 to cover expenses and terminated the agreement. No milestones ever paid. Where is the validation.
The terms of the agreement require, unlike in the US, minimum purchase amounts in Mexico and Brazil plus a $1 million payment upon approval in each country. I don't think they are in a hurry.
Contract does not contain the term "best efforts".
1.35. “ Commercially Reasonable Efforts ” means, with respect to a particular Party’s specific obligations under this Agreement with respect to a Product and a country in the Territory at the relevant point in time, that level of efforts and application of resources that is**** consistent with the usual practice followed by that Party in conducting similar activities****, in the exercise of its reasonable scientific, business or regulatory judgment, but in no event less than the level of efforts and resources consistent with the commercially reasonable practices of the research-based pharmaceutical industry in the applicable country in the Territory, relating to other prescription pharmaceutical products*** owned or licensed by it***** or to which it has exclusive rights that have market potential.
When have you seen a TV commercial for any other Eisai product?
I wonder if this is how TROV tests will be marketed. Direct to consumer advertising, development of shipping packaging, prepaid shipping all pretty expensive. Notice this test is covered by Medicare. http://wwwDOTcologuardtestDOTcom
Agree. That's why I consider all these small cap biotechs trading vehicles. If I hadn't traded THLD for 3 years before they managed to bomb on two PH 3 trials at the same time I woulda got killed. Lost a small amount as it was. GL
Why were Shuh and Zaniboni working to establish a different company? Greed? Are you sure?
Why did Possard leave a company if it was on the verge of huge success? Pouting over not being named CEO?
Why did TROV have to entice Erlander to stay on with 50,000 shares that vest in 9 mos if success is around the corner?
Why has the HPV test launched 3 years ago not generated revenue?
So, I agree the story of the science sounds good but what about the people telling the story? With 50% of the people making up TROV's BOD also making up 50% of Gensignia's BOD, and at one time the CEO,CFO,and CSO of TROV also working at Gensignia concurrently with TROV employment don't you have just a smig of doubt?
Sure, this stock could go to double digits anytime as demonstrated in the past. That's a possible but there are 2 negatives that are almost certain. First, dilution. They have 6 quarters worth of cash at last quarter's burn rate. Companies never go below 4 quarters cash and the burn is increasing due to new hires. Second, Hillary will no doubt revisit her rhetoric regarding pharma pricing during the presidential campaign and we saw what that did to bio stock prices. I have other thoughts that keep me negative towards this company but at the risk of causing heart attacks among the true believers I'll keep those to myself. Short term trading vehicle is how I view this stock.GL