BMSN**Why a quick FDA Orphan Drug Approval… Firs
Post# of 5066
Posted On: 07/28/2013 2:13:02 AM
BMSN**Why a quick FDA Orphan Drug Approval… First:
Make no mistake about it that 85% of all IND applications move on to begin clinical trials as can be confirmed from the link below. So I think it is very safe to expect IND FDA Approval from this first round of FDA Approvals.
Second (or Next):
Next, because of HemaXellerate I™ being eligible for Orphan Drug designation, there will be around a 70% chance that the FDA will give an accelerated approval to bypass the normal lengthy FDA Approval Process of going through Phases I, II, III, & IV that usually lasts many months and years and grant BMSN this final/full FDA Approval to move forward in as little as 60 days. You will read why I say this later within this post. Below is confirmation from the FDA website that HemaXellerate I™ will be classified as an Orphan Drug because of its use to combat Aplastic Anemia:
Because of HemaXellerate I™ being eligible to obtain Orphan Drug Status, this means the following below can work towards benefiting BMSN and its shareholders:
1**60 days or Less Accelerated final/full FDA Approval.
2**Bypass lengthy Phase I, II, III, IV FDA Approval Processes.
3**The FDA has been offering incentives for developing treatments for rare diseases since 1983, when the Orphan Drug Act became law.
4**The FDA wants to double the number of orphan drug designations that their office approves in the next five to 10 years.
5**The Orphan Drug designation comes with a 50 percent tax credit on any clinical trials that need to be conducted.
6**Drug fees, which currently cost around $1.6 million for one drug application, are eliminated.
7**The company that succeeds in getting final FDA approval will be allowed exclusive drug marketing rights for seven years.
8**Major medical companies see “confirmed” future value to be 100% on board and supportive.
9**Dr. Cote says the designation brings the new drug to the attention of investors.
Below is a quote from Dr. Timothy Cote:
Quote:
--------------------------------------------------------------------------------
"When you get orphan status designation, you go up on our website saying that the FDA has given a nod that this is promising for this rare disease," said Cote. "And then the venture capital rains down from the heavens.
Make no mistake about it that 85% of all IND applications move on to begin clinical trials as can be confirmed from the link below. So I think it is very safe to expect IND FDA Approval from this first round of FDA Approvals.
Second (or Next):
Next, because of HemaXellerate I™ being eligible for Orphan Drug designation, there will be around a 70% chance that the FDA will give an accelerated approval to bypass the normal lengthy FDA Approval Process of going through Phases I, II, III, & IV that usually lasts many months and years and grant BMSN this final/full FDA Approval to move forward in as little as 60 days. You will read why I say this later within this post. Below is confirmation from the FDA website that HemaXellerate I™ will be classified as an Orphan Drug because of its use to combat Aplastic Anemia:
Because of HemaXellerate I™ being eligible to obtain Orphan Drug Status, this means the following below can work towards benefiting BMSN and its shareholders:
1**60 days or Less Accelerated final/full FDA Approval.
2**Bypass lengthy Phase I, II, III, IV FDA Approval Processes.
3**The FDA has been offering incentives for developing treatments for rare diseases since 1983, when the Orphan Drug Act became law.
4**The FDA wants to double the number of orphan drug designations that their office approves in the next five to 10 years.
5**The Orphan Drug designation comes with a 50 percent tax credit on any clinical trials that need to be conducted.
6**Drug fees, which currently cost around $1.6 million for one drug application, are eliminated.
7**The company that succeeds in getting final FDA approval will be allowed exclusive drug marketing rights for seven years.
8**Major medical companies see “confirmed” future value to be 100% on board and supportive.
9**Dr. Cote says the designation brings the new drug to the attention of investors.
Below is a quote from Dr. Timothy Cote:
Quote:
--------------------------------------------------------------------------------
"When you get orphan status designation, you go up on our website saying that the FDA has given a nod that this is promising for this rare disease," said Cote. "And then the venture capital rains down from the heavens.
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