CB-03-01 - new antiandrogenic

[stan]

wow thank you very much guys! much appreciated.

[Pentarou]

Does anyone know what the European Union equivalent to the FDA and its 'phases' are, and if they know of there's information on how far along CB-03-01 is along with it?

[sascha]

Yes hellouser is right. phase 1 is safety and efficiency to some degree. Sorry

[hellouser]

phase 1 is for showing that the drugs does something.
phase 2 is for testing for a longer period of time, around 1,5 years+. There they also find out the perfect dosage.
phase 3 is the phase where they meet with the FDA and clear about the steps that need to be done to enter the market. another 6 month - 1 year.

a wikipedia search will bring you good information about it.

Phase I is safety.

[sascha]

what happens after phase 3? are there only three phases? what is motive behind each phase? sorry i am a newbie.

phase 1 is for showing that the drugs does something.
phase 2 is for testing for a longer period of time, around 1,5 years+. There they also find out the perfect dosage.
phase 3 is the phase where they meet with the FDA and clear about the steps that need to be done to enter the market. another 6 month - 1 year.

a wikipedia search will bring you good information about it.

[tommy e]

what happens after phase 3? are there only three phases? what is motive behind each phase? sorry i am a newbie.

I think they are like 5 phases, but drugs undergoing phase 3 trials can be marketed under FDA norms, the rest phases are postmarketing.

[stan]

Yes, as long as the proof of concept phase II results are similar to their initial study results we should see CB out in 3-5 years max.

what happens after phase 3? are there only three phases? what is motive behind each phase? sorry i am a newbie.

[FearTheLoss]

Yes, as long as the proof of concept phase II results are similar to their initial study results we should see CB out in 3-5 years max.

[Scalpology]

If CB will come out in 5 years, how come people have gotten and tested it before now?

[Sogeking]

"Hello,

I'm very interested in your companies progress with the CB compound for hair loss. I see that you have finished phase 1 trials. When are phase 2 trials beginning?"

"Hi *********,
We have completed phase II acne and will start with phase III in the coming months. We are in proof of concept phase II for alopecia right now.
Best regards

Dr. Chris Tanner
Chief Financial Officer

cid:image001.jpg@01CD06A8.A2EBD7D0
Via C. Colombo, 1
20020 Lainate, Milan - Italy
Phone: + 39 02 93 33 7453
Fax: + 39 02 93 33 7604
CTanner@cosmopharma.com
www.cosmopharma.com"

NOICE!!!

CB will come within 5 years. This is good. Replicel will follow. With pilofocus they might be some kind of a bridge towards the cure we are waiting for.

[FearTheLoss]

"Hello,

I'm very interested in your companies progress with the CB compound for hair loss. I see that you have finished phase 1 trials. When are phase 2 trials beginning?"

"Hi *********,
We have completed phase II acne and will start with phase III in the coming months. We are in proof of concept phase II for alopecia right now.
Best regards

Dr. Chris Tanner
Chief Financial Officer

cid:image001.jpg@01CD06A8.A2EBD7D0
Via C. Colombo, 1
20020 Lainate, Milan - Italy
Phone: + 39 02 93 33 7453
Fax: + 39 02 93 33 7604
CTanner@cosmopharma.com
www.cosmopharma.com"

[hellouser]

Guys I just spoke with a representative for Cosmo and they are actually well underway with their "phase II proof of concept trials" for alopecia. They are starting phase III for acne in the coming months. This is a great sign, it looks as if they, as well as other companies, are further than we are aware of.

FTL

Can you copy/paste the email conversation???

[FearTheLoss]

Guys I just spoke with a representative for Cosmo and they are actually well underway with their "phase II proof of concept trials" for alopecia. They are starting phase III for acne in the coming months. This is a great sign, it looks as if they, as well as other companies, are further than we are aware of.

FTL

[Duke]

Correct, FearTheLoss

according to this they are done with phase 1 and about to start phase 2

http://www.cosmopharmaceuticals.com/~/media/Files/C/Cosmo-Pharmaceuticals/product_pipeline_03_14.pdf

[FearTheLoss]

I thought they were already done w phase 1. I believe it says that on their site.