FDA, Food and Drug Administration
ODA, Orphan Drug Act
Regulatory harmonization
In an effort to reduce the burden on manufacturers applying for orphan drug status, the FDA and EMA agreed in late 2007 to utilize a common application process for both agencies. However, the two agencies will continue to maintain separate approval processes.
In order to encourage the development of drugs for orphan diseases, the ODA included a number of incentives including seven-year market exclusivity for companies that developed orphan drug, tax credits equal to half of the development costs, later changed to a fifteen-year carry-forward provision and a three-year carry-back that can be applied in profitable year, grants for drug development, fast-track approvals of drugs indicated for rare diseases, and expanded access to the Investigational New Drug Program. The law was also later amended to waive user fees charged under.
ANP are completing ODA which means ATL1103 will fast track approvals and is eligible these said tax rebates on development etc... So we are nearing a free carry stage for ANP once ODA is complete. Phase II takes 18 weeks and 3 is red tape.
President Ronald Reagan signed the ODA into law. Under the ODA drugs, vaccines, and diagnostic agents would qualify for orphan status if they were intended to treat a disease affecting less than 200,000 American citizens. In order to encourage the development of drugs for orphan diseases, the ODA included a number of incentives including seven-year market exclusivity for companies that developed orphan drug, tax credits equal to half of the development costs, later changed to a fifteen-year carry-forward provision and a three-year carry-back that can be applied in profitable year, grants for drug development, fast-track approvals of drugs indicated for rare diseases, and expanded access to the Investigational New Drug Program. The law was also later amended to waive user fees charged under PDUFA.[1]
http://en.wikipedia.org/wiki/Orphan_Drug_Act_of_1983
Blue sky is very close. ANP is a strong buy IMO
- Forums
- ASX - By Stock
- atl1103 anti cancer medications
FDA, Food and Drug AdministrationODA, Orphan Drug ActRegulatory...
-
- There are more pages in this discussion • 70 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
Featured News
Add PER (ASX) to my watchlist
(20min delay)
|
|||||
Last
10.0¢ |
Change
0.000(0.00%) |
Mkt cap ! $90.15M |
Open | High | Low | Value | Volume |
10.5¢ | 10.5¢ | 10.0¢ | $47.27K | 463.5K |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
3 | 319942 | 10.0¢ |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
10.5¢ | 86442 | 3 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
3 | 319942 | 0.100 |
3 | 113179 | 0.099 |
1 | 13000 | 0.098 |
2 | 130927 | 0.097 |
1 | 10004 | 0.096 |
Price($) | Vol. | No. |
---|---|---|
0.105 | 86442 | 3 |
0.110 | 290000 | 4 |
0.115 | 601850 | 5 |
0.120 | 275642 | 8 |
0.125 | 65000 | 2 |
Last trade - 16.10pm 27/09/2024 (20 minute delay) ? |
Featured News
PER (ASX) Chart |