Replies to post #348262 on NorthWest Biotherapeutics Inc (NWBO)

[highwayman4life]

Lol...perhaps you only follow unicorn trials?

Many clinical trials are subject to a requirement that their results be reported to one or more registries, in formats specified by the particular registry. These summaries, which are publicly available on the registry website, are generally limited to major outcomes and adverse events.7 As mentioned in Chapter 3, the Food and Drug Administration Amendments Act of 2007 (FDAAA) requires results of trials of FDA-regulated products to be reported to ClinicalTrials.gov within 12 months of study completion. However, a 2012 study found that the results of 30 percent of 400 clinical trials had neither been published nor reported on ClinicalTrials.gov 4 years after study completion (Saito and Gill, 2014). Following this study and others showing a similar dearth of reporting of results for registered trials, the U.S. Department of Health and Human Services (HHS) has proposed a new rule requiring that results of trials of unapproved products be reported to ClinicalTrials.gov within 12 months of study completion. NIH has also proposed a draft policy calling for all NIH-funded trials not subject to the FDAAA (e.g., trials of surgical or behavioral interventions and phase 1 trials) to also be reported to ClinicalTrials.gov within 12 months of study completion (Hudson and Collins, 2014).

After concluding that clinical trial data should be shared only after a moratorium following completion of the trial, the committee considered how long that moratorium should be. In addition to balancing the countervailing interests and goals discussed above, the committee weighed the following pragmatic considerations. First, as noted above, the available data on the time to publication after completion of a clinical trial suggest that the percentage of trials published increases continuously over time, with a leveling off between 40 and 60 months after completion. Second, the original investigators in the clinical trial have a head start relative to secondary users that is longer than the moratorium period because, even after obtaining access to clinical trial data, a secondary investigator will require time to become familiar with the data set, to plan and run data analyses, and to prepare a manuscript for submission to a medical journal. Third, changing the incentives and expectations for sharing data and publishing results of clinical trials may change investigator behaviors. If investigators know they will share data at a certain time after completion of a trial, they may alter their planning to attempt to obtain appropriate levels of funding and staffing or arrange to collaborate so as to publish the primary and some secondary analyses within the moratorium period. For junior investigators planning to be lead author in secondary analyses, it will be important to carry out those analyses as soon as possible so that they can be submitted shortly after the primary paper has been accepted.

None of us know how long it will take for release of TLD and there is no set standard. Given what I feel is the significant relevance of this trial, I would prefer that all the i's be dotted, t's crossed and present the data in the most accurate and acceptable format...a journal publication. How long does this take? Well, it ain't 6 weeks!!

At least progress has been made...your stance used to be that data from the DCVax trial would never be released. Now, you state it will be released, just not this year. LOL Care to go ahead and state what you think the data will show once it is released THIS YEAR? Once the positive data is released, what will your game plan be to discredit the data?