Clinical studies

To date, XNT data is unavailable in clinical pharmacology and clinical efficacy studies [57]. Not every new candidate compound discovered is fully developed and marketed [58]. We reveal that some issues restraining the availability of clinical trials are funding limitations and difficulty getting approvals from Food and Drug Administration (FDA). Frohlich supported that one of the complexities surrounding clinical research is insufficient funding to conduct modern research [59]. Aside from funding, strict ethical and regulatory compliance enforced by our social structure [59] might prolong the new drug developmental process. The major concern of clinical research is the safety and efficacy of the candidate compound [58]. It normally takes 5–6 years for a candidate drug to be submitted in a new drug application (NDA) to the FDA. Then, it required 6–10 months to complete the review of all the safety and efficacy data [58]. To overcome the delay of widespread access to new therapies, questionable data and ethical issues must be resolved. We suggest that necessary safety data, efficacy data and overall risk/benefit analysis are important key elements in successful sponsorship of XNT for future clinical studies.
Molecular and cellular mechanisms of XNT anticancer effects

XNT is a potential suppressor of carcinogenesis. Seeing that several monophenolic groups possess cytotoxic activities, the cytotoxic effect of XNT may be contributed by its phenol group [13]. Its anticancer mechanisms are comprehensive and diverse by modulating different levels of cellular growth and apoptosis. The apoptotic morphology is usually characterized by DNA fragmentation, cell shrinkage, elongated lamellipodia and chromatin condensation [7, 18, 6062]. Taken together with the anticancer activities that have been reported [7, 1214, 18, 26, 41, 6068], we suggest that the anticancer mechanisms of XNT are closely associated to its antioxidative and anti-inflammatory activities, induction of apoptosis and cell cycle arrest.

### Language ###
English

### Assessment ###
We can ask about the typical duration for a new drug application review by the FDA, which is clearly stated in the text.

### Query ###
How long does it take for the FDA to review a new drug application?
How long does it take for the FDA to review a new drug application?