Regen BioPharma Inc (RGBP)

[cvinvestor]

My understanding as well. Preclinical safety trials in US do not include human patients, but the experimental testing has to be done in a way that indicates probable effectiveness as well as safety in humans.

As you will recall, BMSN conducted 2 experimental trials already on mice and submitted that data hoping for approval. From a previous PR about phone call with FDA cell experts, we learned that they are not satisfied with the data (we don't know why other than they were not done in a GLP lab). It seems reading between the lines that the FDA is looking for a specific test module that will give them the key data indicators they are looking for and while the previous BMSN HemaX experiments might have resulted in positive data results, the key data operators the FDA guys were looking for were not there and so they have been discussing the protocol for further safety experiments. BMSN submitted those yesterday and will need to wait up to 30 days (let's hope its 3 instead) for a thumbs up or down to go ahead with the PRE-CLINICAL safety experiments.

We expect these experiments will result in the data necessary for clinical trial approval. How long this will take is a guessing game since we don't know the protocol, but those saying this week or next for clinical trial approval are living a fairy tale or don't understand English.

Most likely we are talking weeks to several months for conclusive safety data.

AIMO