Monday, June 28, 2010 11:46:06 PM
So glad to see some Clinuvel discussions that aren't dated 2003!
I believe this stock has incredible potential, but it will be years down the road before we see it. By going the EPP route, Clinuvel's strategy is to first get FDA approval VIA a disease with very little treatment options. This is a very smart path to take on their part. If the drug is approved, it will be much easier to begin prescribing it for off label use later on down the road. Then eventually, it might be legally prescribed for tanning.
Think about Propecia, the only drug prescribed for hair loss. Proscar (Finasteride) was approved by the FDA for prostate enlargement. When Merck discovered that the side effects were mild hair growth, they were able to get it approved by the FDA for hair loss, because it had already been through rigorous testing and had proven its safety on the market.
If Clinuvel gets approved by the FDA, I envision two big possibilities:
1.) Big pharma could realize the future potential of the drug and snatch it up.
2.) Clinuvel will begin selling the drug for EPP for a few years, allowing the drug's safety to be proven. Eventually, it will seek FDA approval for sun protection or tanning.
So... the roller coaster is not over by a long shot. Getting FDA approval is the first big step. The second big step will be proving the drug's safety in the market place. And finally, the last step will be the day it is approved for tanning, which is when your stock potentially makes you millions.
We've still got a long way to go though, and the illegal, counterfeit version of Melanotan does not help things one bit.
I believe this stock has incredible potential, but it will be years down the road before we see it. By going the EPP route, Clinuvel's strategy is to first get FDA approval VIA a disease with very little treatment options. This is a very smart path to take on their part. If the drug is approved, it will be much easier to begin prescribing it for off label use later on down the road. Then eventually, it might be legally prescribed for tanning.
Think about Propecia, the only drug prescribed for hair loss. Proscar (Finasteride) was approved by the FDA for prostate enlargement. When Merck discovered that the side effects were mild hair growth, they were able to get it approved by the FDA for hair loss, because it had already been through rigorous testing and had proven its safety on the market.
If Clinuvel gets approved by the FDA, I envision two big possibilities:
1.) Big pharma could realize the future potential of the drug and snatch it up.
2.) Clinuvel will begin selling the drug for EPP for a few years, allowing the drug's safety to be proven. Eventually, it will seek FDA approval for sun protection or tanning.
So... the roller coaster is not over by a long shot. Getting FDA approval is the first big step. The second big step will be proving the drug's safety in the market place. And finally, the last step will be the day it is approved for tanning, which is when your stock potentially makes you millions.
We've still got a long way to go though, and the illegal, counterfeit version of Melanotan does not help things one bit.
Recent CLVLY News
- advancing peptides for photomedicine and vitiligo care at AAD 2026 • GlobeNewswire Inc. • 04/15/2026 06:18:07 AM
- CLINUVEL to advance novel pharmaceutical formulations in preclinical program • GlobeNewswire Inc. • 09/29/2025 02:56:51 AM
