Replies to post #10508 on BioCorRx Inc. (BICX)

[Kizersosae]

I stated I am not 100%, however It was explained to me by a person I know in Pharmaceuticals that...

505B2 is so that a company can do LESS studies in the NDA process. LESS studies means less money needed to be spent. It’s not necessarily a short cut, but it can cut down on some time and money. It’s all case by case basis. He also said the PRE IND is a very important step, but be prepared there may not be this huge PR that you want. It’s more of a set up for the rest of the NDA process.

I’m just passing on what I was told. Do your own research.

However, IMO I think a positive PRE IND could bring in the financial backer interest that we need.

[Kizersosae]

https://www.news-medical.net/news/20130129/Meridian-reports-positive-pre-IND-meeting-with-FDA-for-ML061.aspx

This article I found talks about how the FDA responded with positive feedback to the company in the article. Also the article says the company was told by the FDA that 505B2 was an appropriate path to take. So I guess it wasn’t technically granted in the meeting but it sure as hell was alluded to with those words.

So I guess there is a chance for 505B2 to be green lighted... gonna be an exciting day to say the least!