NorthWest Biotherapeutics Inc (NWBO)

[highwayman4life]

Good news for NWBO longs. Their stock is disconnected from the overall market.

As you are from what lies ahead for Regualtory Approval (all 4 RA's) for DCVaxL using EC/RWD.

The fast-changing and expanding I-O treatment landscape highlights the need to better inform treatment decisions through rapid assessment of how new therapies affect patient outcomes. As discussed previously, clinical trials are the established mechanism for such assessments, but they can take a long time to conceive and conduct. Indeed, while the usual length for a Phase III trial is 1–4 years [43], many clinical trials experience significant delays to recruitment, which often leads to a further increase in the length of the study [44]. Since many new I-O agents address significant unmet medical needs, the time required to develop a trial protocol, recruit patients and conduct a clinical trial might be seen as an unacceptable delay to patients accessing new and effective treatments. Moreover, clinical trials for orphan drugs (i.e., those targeting rare diseases), where unmet medical needs may be greatest, on average take nearly twice as long as trials of nonorphan drugs [45]. This is a major consideration as I-O therapies are increasingly being extended to smaller patient populations with rarer conditions. Even in the case of less-rare cancers, recruitment into later-stage I-O studies (i.e., Phase III RCTs) can be challenging as data from earlier studies may be robust enough that investigators feel that clinical equipoise has been lost and are reluctant to enroll into larger trials where SoC has already been surpassed. In addition, patterns of response with I-O therapies are somewhat distinct from other cancer treatments and are often characterized by durable tumor suppression and associated long-term survival. This has led to calls for innovative methodologies and study designs [46,47], suggesting that traditional clinical trial approaches may not be optimal for assessing long-term effects of I-O therapy. A further consideration is the large number of emerging I-O agents [13]. This rapid expansion may result in a need to compare new agents and new combination regimens against each other and/or against an expanding list of SoC treatments. However, conducting multiple RCTs to facilitate these comparisons may be cost and resource prohibitive. In this environment, there is a strong case for increased acceptance on the part of regulatory bodies to submissions based on limited clinical trial data supplemented with RWD.

With enhanced communication and greater alignment between regulators and industry, the hope is that a clear RWE roadmap will emerge in the upcoming years facilitating routine generation of ‘regulatory-grade’ RWD to support the approval of new I-O therapies.
https://www.futuremedicine.com/doi/10.2217/fon-2020-0591