Replies to post #392604 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

I won’t claim I know you are correct. But let me suggest a scenario where what you say functionally is the same thing.

As indicated by the company, they intended to apply for fast track status, once they had the data. Additionally, fast track or priority review or any of the special status designations that also involved priority review effectively, would be necessary to open the door for Project Orbis. So for efficiency’s sake, the process really almost requires that they file as they indicated.

Let’s say they started the fast track process, and instead of the usual, early application, it is being done on the tail end.

Fast Track opens the door to rolling review and accelerated approval. The criteria are listed below for getting Fast Track, and then a description of the benefits including the benefits of rolling review and accelerated approval. And then I have previously indicated some of the scrutiny and necessary efforts they'd have to make to get their manufacturing lined up reasonably believably for the regulators to benefit from all of this effort. As Flipper says, they want a drug that might become the new Standard of Care (SOC) to be available to patients. IF it isn't, and it's approved, patients and their families would likely be annoyed. I think the company has more than enough contingencies for manufacturing, via Sawston and then third parties. But they may have to go through certain steps to ensure that they've made an effort that satisfies the due diligence of all the regulators.A lot of this is also relevant to their ultimate application for approval of the BLA. So it's certainly possible that everything, coming at the end as it is in this case, is rolling into an accelerated approval or rolling review with lots of back and forth with the FDA. I think what you're saying, could be derived from such a set of circumstances. I am just speculating.

https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track

From the FDA:

“Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.

Determining whether a condition is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the condition, if left untreated, will progress from a less severe condition to a more serious one. AIDS, Alzheimer’s, heart failure and cancer are obvious examples of serious conditions. However, diseases such as epilepsy, depression and diabetes are also considered to be serious conditions.

Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy.

Any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need. If there are available therapies, a fast track drug must show some advantage over available therapy, such as:

Showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes;

Avoiding serious side effects of an available therapy;

Improving the diagnosis of a serious condition where early diagnosis results in an improved outcome;

Decreasing a clinical significant toxicity of an available therapy that is common and causes discontinuation of treatment
Ability to address emerging or anticipated public health need;

A drug that receives Fast Track designation is eligible for some or all of the following:

More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval;

More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers;

Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA;

Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.

Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients. “

This might explain why they are, it is said, so incredibly busy.