Why report negative info, when you can go silent and move on to the next thing. Reality is, lympro is moving into the forefront and into commercialization.
AMBS keeps up with the TIMES... I suggest all to read this article from the FDA Website
Flexible Trial Design
People with serious or life-threatening illnesses, particularly those who lack good alternatives, have told us repeatedly that they are willing to accept greater risks in order to gain access to new approved treatments.
FDA has long taken a flexible, rather than one-size-fits-all, approach to clinical trial design, urging that trials be designed as efficiently as possible to determine whether new drugs under investigation are safe and effective for their intended use, taking into account the severity and rarity of the disease and unmet need. A new study published in the Journal of the American Medical Association found that more than a third of 188 novel therapeutic drugs for 208 indications (uses) between 2005 and 2012 were approved on the basis of a single pivotal clinical trial, and in many cases, trials involved relatively small groups of patients for shorter durations.1 All of this is possible, of course, when the drugs demonstrate strong beneficial effects.
Over 60 percent of drugs for rare diseases are approved on the basis of a single pivotal study, often because the cause of the disease is well understood and the pivotal study is supported by evidence of pertinent pharmacological effects, and because the natural history of untreated disease for many orphan conditions is well-characterized. All patients in such trials are given the new treatment, and the results are compared with the well-characterized natural history.2 Thus, for example, last year, FDA approved Imbruvica (ibrutinib), a treatment for mantle cell lymphoma, based on an “open-label, single-arm trial,” which means that every patient received the treatment and the trial was unblinded; i.e., both patients and researchers knew they were receiving the orphan drug under study. The results were compared to how well the 111 participating patients had responded to previous treatment for their disease. These designs are appropriate where there are objective responses (tumor shrinkage and recurrence, survival) where observational bias is limited, and where the natural history is clearly different from what treated patients experienced (tumors do not shrink spontaneously; survival is greatly increased).
In some cases, of course, small trials will not do the job. Some trials require large numbers of patients to demonstrate drug effects. This is often the case in studies of cardiovascular disease, where study endpoints, such as heart attack or stroke, while important, are not common. Adaptive Trial Designs
FDA is also actively involved in developing adaptive trial designs, including designs with Bayesian adaptations based on interim assessments of biomarkers. Using this approach we try to find ways to adapt a clinical trial to the circumstances of the specific questions being asked in a way that is as efficient as possible but still gives us confidence in the results. The goal of these designs is to reduce trial duration and trial size. Importantly, these adaptations are performed with close attention to statistical rigor.
FDA is also conducting an internal research project to evaluate the amount and type of safety data required for new indications for cancer drugs. The goal is to identify ways to reduce the burden on sponsors, when submitting supplemental applications as well as regulatory review time, while ensuring patient safety. This research will be completed in November 2014. Clinical Trial Enrichment
You also expressed interest in new tools to lower the cost of clinical trials. FDA issued guidance in December 2012 that explained how those developing drugs can use potentially powerful strategies to demonstrate a drug’s effectiveness using clinical trial data.3 Appropriate use of what we call clinical trial enrichment strategies could result in smaller studies, shortened drug development times, and lower development costs.
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