It will also lead the clinical development, regulatory approval and commercialization in the U.S., while Bharat Biotech will ship an initial supply to the U.S. after the FDA grants an EUA. Ocugen will have the U.S. rights to the vaccine candidate and will receive 45 percent of any future profits. FDA APPROVAL AROUND THE CORNER!!! Ocugen announced the FDA granted the fourth Orphan Drug Designation (ODD) for OCU400 in the treatment of PDE6B gene mutation-associated retinal diseases.Retinitis Pigmentosa (RP) caused by PDE6B mutation is an inherited retinal dystrophy that leads to blindness by midlife and is characterized by the progressive loss of photoreceptors, with or without the loss of retinal pigment epithelium cells. They haven't done any clinical studies so far in the United States, Ocugen, while they were in talks to license it, started discussions with the FDA about potential path to authorization and approval. MALVERN, PA, September 25, 2017 (PR Newswire) Ocugen, Inc., a clinical stage biopharmaceutical company developing novel treatments for sight-threatening diseases, today announced that the U.S. Food and Drug Administration (FDA) accepted its Investigational New Drug (IND) application for OCU310 (brimonidine/steroid combination therapy), a topical formulation for the … Ocugen is talking with the FDA about a path to obtaining EUA and ultimately approval. In retrospect now that I think of ocugen as we get closer to phase III I cant imagine that the stock doesnt hit the triple Digits. If clinical trials prove successful, Ocugen will be seeking regulatory approval to commercialize use in the United States in exchange for 45% of the vaccine’s profits. So in this video, we will be going over updates on the stock Ocugen Ocgn. The company is in talks with the U.S. Food and Drug Administration (FDA) regarding an Emergency Use Authorization (EUA) pathway for its candidate. I mean think about this for a minute: based on all the news regarding how much better, cheaper and more effective it is compared to the other circling vaccines. With no approved treatments that slow or stop the ... Chief Executive Officer and Co-Founder of Ocugen. $17.75 to $36.42 in 3 days. However, it's highly likely that the FDA will require clinical studies to be conducted in the U.S. first. Then back down to $19.10 11 days later. Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and … Please go look at Moderna's (MRNA) price action in March of last year. Then the climb to $35.10 4 days later.