Liberation wrote:
Any news on the fast track designation? How much would it shorten its entrance to the market? Does anyone know if it might be good for ppms or only for RRMS and SPMS?
Good questions but Opexa's financial situation is the most immediate limiting factor and it's impossible to tell when or if it will resolve. Secondly this is a situation which phase I and II haven't shown safety problems but still requires further research and clinical trial time and now throw in it being fast tracked.....there are just too many variable factors to make a "how long" guess.
Earlier there were interesting reasons to think that Tovaxin had some effacacy on SPMS and PPMS, partially because Tim Wesner's neuro evidently felt that he had progressed to SPMS but that all remains to be determined as does whether or not Tovaxin even offers anything to people with RRMS.
Before putting too much interest into Tovaxin keep in mind that at last count the necessary mrtc's could only be isolated from the blood of about 50% of people with MS to make Tovaxin for them although the company had hoped to eventually get that number up to about 95%.
http://www.fda.gov/forconsumers/byaudie ... 128291.htmQuote:
Fast Track
Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious diseases 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 diseases.
Determining whether a disease 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 disease, 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 diseases. However, diseases such as epilepsy, depression and diabetes are also considered to be serious diseases.
Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially superior to existing therapy.
Any drug being developed to treat or prevent a disease with no current therapy obviously is directed at an unmet need. If there are existing therapies, a fast track drug must show some advantage over available treatment, such as:
Showing superior effectiveness
Avoiding serious side effects of an available treatment
Improving the diagnosis of a serious disease where early diagnosis results in an improved outcome
Decreasing a clinically significant toxicity of an accepted treatment
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 correspondence from FDA about such things as the design of the proposed clinical trials
Eligibility for Accelerated Approval, i.e., approval on an effect on a surrogate, or substitute endpoint reasonably likely to predict clinical benefit
Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA, and
Dispute resolution if the drug company is not satisfied with an FDA decision not to grant Fast Track status.
In addition, most drugs that are eligible for Fast Track designation are likely to be considered appropriate to receive a Priority Review. 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 disease.
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.
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