Regenicin Inc (RGIN)

[stk_maniac]

Overview
As we move into 2018, the Company will continue to pursue its goal of obtaining FDA approval for its product NovaDerm. The product is well positioned to enter clinical trials. At this point the most significant gating item is financing. We have been consistently working with several investor groups and we remain confident that the necessary funding will be secured.
NovaDerm is well positioned to enter clinical trials due to the following:

- NovaDerm has an extensive documented history of clinical research.
- Additional independent product research has demonstrated the products superiority.
- NovaDerm has been awarded Orphan Product Designation by the FDA, which indicates the value and humanitarian benefits of the product.
- The positive results of the Pre-IND Application meeting between the Company and the FDA, in which both parties fully agreed on a pathway forward to enter the clinical trials.
- The Company has entered into two critical contracts to secure Closed Herd collagen and to fabricate the collagen scaffolds, the platform on which NovaDerm is grown.
- The company has selected a Clinical Research Organization, (CRO), to assist in the management of the clinical trials and the Company has identified a Principal Lead Investigator, a medical advisor for the clinical trials.
- In conjunction with CRO, two clinical sites will be selected to host the clinical trials.


Based on our agreement with the FDA, the clinical trials call for 3 patients initially and then 7 additional patients. The entire episode of care is estimated to be 1-4 months, depending on the severity of the burn. NovaDerm’s protocol is similiar to that currently performed with split thickness allograph and other temporary skin substitutes. Therefore, there is no additional physician training required. The chance of an immune system rejection is greatly reduced because NovaDerm is produced from the patient’s own cells. Finally, patient recruitment should be very fast because it will require fewer patients because of it’s Orphan status. When NovaDerm is approved to start clinical trials, NovaDerm may be used by any of the 150 burn centers for Humanitarian Use as long as the burn center agrees to follow the clinical trial protocol on file with the IND.



As aforementioned, NovaDerm is well positioned to enter and successfully complete the clinical trials for FDA product approval. Currently, our main task is to raise the adequate funding to complete the IND application and begin the clinical trials, which we estimate at $3.5 million to $4.5 million.
https://www.sec.gov/Archives/edgar/data/1412659/000166225218000034/rgin10q.htm