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Re: ~ TRT ~ post# 64633

Thursday, 04/11/2013 11:25:24 PM

Thursday, April 11, 2013 11:25:24 PM

Post# of 158400
have you done any DD?

cleary around Q3 -- they have already given guidance to that effect.

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let me give you the real truth about how drugs get to clinical trials.

unless the company is one of the few multi-billion$ conglomerates, trials DO NOT START 30 DAYS AFTER IND APPLICATION TO THE FDA. I know, shocking right? allow my to explain:

you see, it takes years of preparation and hard work for a small company just to get to the point of applying for an IND with the FDA as outlined by the president of Regen here:


Now, after IND application has been received by the FDA -- there is a question/answer period between the company and FDA. After the FDA is satisfied, the IND IS NOT YET APPROVED!!!! Nope, next the IND must be reviewed by the hospital/institution where the trials will inevitably take place. That review is much like the FDA review but more in depth.

Whew, difficult eh...are you still interested in more of the real truth? ok, read along:

Once the the hospital/institution is satisfied, they pass their finding back to the FDA who reviews it all once more and then gives approval to the company to start phase 1 clinical trails.

"so now they can start experimenting on human right steve??"

NOPE, NOT YET.

the real truth is that:

once given approval to go ahead: now the company must start the process of finding/soliciting suitable potential patients for phase 1 trials.

each potential candidate must be properly screened/vetted by the company and the hospital/institution. each potential candidate.

this takes time.

Now, the real truth about everything that i have written above is: that its is all just the proverbial tip of the iceberg - there is alot more planning and organizing going on behind the scenes.

"but, lolz, that just proves my point steve: there is no way a small company like regen can do all that by themselves!!!lol!"

true, they cant - but here is somemore real truth: The company has contracted Cromos pharma from Europe to help with getting the IND to clinicals.

oh and the money - they have plenty: afterall, what has this dilution been for?

its already been mentioned that phase 1 typically costs between 500,000-800,000$ (someone, correct me if i am wrong, that was off the top of my head).

again, if you watch the video, the president states that they are in the enviable position of not actually needing outside financing:


if you require any more real truth, dont hesitate to ask!

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