It appears that the most time consuming component in bringing a new drug to market is in the testing phases and not with the FDA approval process. With this in mind, our best hope for PV-10 is with a shortened phase III trial along with some type of accelerated FDA approval. A shortened PIII trial would be of the most benefit to share holders by substantially reducing the study costs and by reducing the overall time frame in bringing PV-10 to the market place. This could potentially shave many months if not years off of the entire process.
Another bright spot for PV-10 is with the Accelerated Approval process.
"In 1992, the FDA instituted the Accelerated Approval regulation, allowing earlier approval of drugs to treat serious diseases, and that fill an unmet medical need based on a surrogate endpoint. A surrogate endpoint is a marker - a laboratory measurement, or physical sign - that is used in clinical trials as an indirect or substitute measurement that represents a clinically meaningful outcome, such as survival or symptom improvement. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval".
Based on the various studies test results, I believe PV-10 more than meets this criterion and therefore would be an ideal candidate for Accelerated Approval.
In order to get entire process accelerated, the sponsor of the drug has to request Fast Track designation. 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.
My questions at this point are:
1) Does anyone know if Provectus has formally requested Fast Track Designation for PV-10???
2) If so, what was the approximate date of the request???
Here's a little FDA Review process 101:
Drug Review Steps:
1. Preclinical (animal) testing.
2. An investigational new drug application (IND) outlines what the sponsor of a new drug proposes for human testing in clinical trials.
3. Phase 1 studies (typically involve 20 to 80 people).
4. Phase 2 studies (typically involve a few dozen to about 300 people).
5. Phase 3 studies (typically involve several hundred to about 3,000 people).
6. The pre-NDA period, just before a new drug application (NDA) is submitted. A common time for the FDA and drug sponsors to meet.
7. Submission of an NDA is the formal step asking the FDA to consider a drug for marketing approval.
8. After an NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed.
9. If the FDA files the NDA, an FDA review team is assigned to evaluate the sponsor's research on the drug's safety and effectiveness.
10. The FDA reviews information that goes on a drug's professional labeling (information on how to use the drug).
11. The FDA inspects the facilities where the drug will be manufactured as part of the approval process.
12. FDA reviewers will approve the application or issue a complete response letter.
In closing, Once again, Yes, very bullish on PV-10/PVCT, both as a viable treatment option and as a sound investment. |
