Replies to post #47412 on Rivulet Media Inc (fka RIVU)

[trazbull]

very cool report...I thought they wouldn't tell peeps outside the company about IND approval info though...anything to add in the regard?

[sizzleweed]

Well then, if you are correct the Hemaxllerate is approved. so we wait for news. It would take them a few days to file the orphan drug paperwork. I am ready to party, the official news will be out soon. BBBBBMMMMMSSSSSNNNNN

[superglide162]

They have not asked for orphan drug statues as of yet, and the FDA I do not believe can confirm a statues of a application, that will come from the company when it is best to do so for them. We as traders should not IMO be calling and bugging the company, we will get the info when it is time.

Have a great day and fantastic weekend!!

[trazbull]

and assuming you are right, your story lines up as they would need to file for orphan status AFTER getting the initial IND ok'd!!! Since the IND was just approved, the most likely hAve yet to file for orphan...BUT IT'S COMING.

[Awchiro]

Orphan drug status takes is an expedited review process of the clinical trials. That's a fact. She either misinformed you or you heard incorrectly.

[reginaliberta]

How did you get this information? Privacy laws on this kind of sensitive info. Not totally convinced.

[serano1]

ITS A PITY YOU DIDNT RECORD IT FOR US

[Joefyffe]

From what I understand. It will be forwarded to the orphan review section shortly after it finishes the IND process and is approved for IND. Then the orphan drug review section will process it within 60 days from the date they receive it. I'm on my phone so don't have the link for that info. I pretty sure it has been posted several times, don't remember by whom. I will find it and post the link later when I get home.

[cookiepuss1]

Do you mean to say she told you that they had completed the process and a decision has been made? I can't imagine she could casually reveal the results like that.

[Shrinky Dynk]

Thanks for the dd

[newbe3]

I just got off the phone with the FDA and she said that she had just received another phone call on the drug and that she has no information on it and it is not public infomration that can be shared.

[stervc]

mscolleen2003, with your call to the FDA…

I 100% believe you. I do believe that the BMSN stem cell drug (HemaXellerate I™) through its wholly owned subsidiary, Regen BioPharma, Inc., has been approved for IND status too. Still, 100% confirmation will do well by the market to ”officially” come from the company or the FDA. I do think that such confirmation is coming.

Also, just so you know and understand the process, I spoke to the people at the FDA Office of Orphan Products Development (OOPD) too. The lady that you spoke with concerning the Orphan drug had never heard of this drug because they won’t hear of it until "after" it is first approved for Investigational New Drug (IND) status.

I was also told by the FDA OOPD that the company will have to first get IND approval for their drug then it will be sent to their office soon after to be awarded Orphan Drug status. I was not given a time frame, but I was told that the FDA tries to get everything done very quickly with the cooperation from the company involved.

This is why they have not heard of it yet. I do believe that it is coming, but read the post below to get an understanding of some previous due diligence (DD) on the issue:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84957802

v/r
Sterling