Replies to post #26949 on Regen BioPharma Inc (RGBP)

[drog68]

No I don't have that answer, but there are a lot of shares being bought up here...let's move

[Meach2]

Phase 1 can pretty much be done any which way.

imo

[GM_FSJ]

Depending on product type and development stage, investigators initially enroll volunteers and/or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary in size and cost, and they can involve a single research center or multiple centers, in one country or in multiple countries. Clinical study design aims to ensure the scientific validity and reproducibility of the results.

https://en.m.wikipedia.org/wiki/Clinical_trial

[cvinvestor]

Crocs, I think your answer is in the presentation of today's PR.

"Because this is an investigator-initiated trial we don't have control over the experimental design, but we are delighted that it is progressing.

David Koos

In my opinion we have gathered several important details from today's PR.
a) This trial is obviously underway and began in March, which is great news
b) This is not the 3rd Qtr trial Lander was referring to in his open letter to shareholders in Jan in my opinion. Koos was keen to point out this was not RGBP's planned human trial, RGBP has no control over it and therefore I deduce that the data will not be data RGBP can use with US FDA as trial results. However, there are benefits as it puts HemaXellerate in the news and in front of BP and positive trials in Mexico can lead to treatments in Mexico and outside the US where other BP may want to license and pay (foreign income stream). Many people from US now travel to foreign countries for treatments that are cheaper or unavailable in US.
c) Results are very encouraging - no bad news. I am completely surprised at both Koos and Lander's cautious and surpressed statements in light of what they say the data shows.
d) Only 5 patients treated thus far at one month interval which means the next 5 patients' results could become news within the next month and we are only 2 months away from 3 month progress update.

If 3 month progress update is also positive (and I don't see any reason to expect otherwise as HemaXellerate's goal is to restore blood cell counts surpressed by chemo, then I think we see more interest in US companies either licensing or helping RGBP pay for US human clinical trials, i.e. 3rd Qtr US trials).

Whether or not this was foreseen and planned from the Jan open letter or not (solicitation for a human trial in Mexico and waiting for positive human trial results there before fully committing money to US trial), we may never know, but the timing of this Mexico trial is welcome, especially getting concrete results from human patients with no adverse effects in any.

A welcome PR today.

1 question that I still have is, will the FDA recognize the results from this testing facility once they complete the 6 month testing with positive results??? Has anyone gotten this answer????