Fred - all I said was the Biodel Phase 3 trials ended in failure. What's fuzzy about that? I'm not trying to spread any fear - just pointing out the facts! They tried to cut costs by trialling in India and screwed up.
On the other matter someone said that Halo would be making a 505(b)(2) approval application. That is usually for ANDA's. If Halo is not selling a generic but a new patented Insulin compound, can they do that with a 505(b)(2) approval application. I'm also unclear as to how they could get access to say HumalinR as Eli Lilly are the only firm allowed to sell it in the US even though it is off-patent. Its rather confusing.
On the other matter someone said that Halo would be making a 505(b)(2) approval application. That is usually for ANDA's. If Halo is not selling a generic but a new patented Insulin compound, can they do that with a 505(b)(2) approval application. I'm also unclear as to how they could get access to say HumalinR as Eli Lilly are the only firm allowed to sell it in the US even though it is off-patent. Its rather confusing.
Recent HALO News
- Form 8-K - Current report • Edgar (US Regulatory) • 04/24/2026 08:06:24 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 04/07/2026 09:13:42 PM
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- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 04/02/2026 10:29:18 PM
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- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 03/23/2026 10:35:07 PM
- Form ARS - Annual Report to Security Holders • Edgar (US Regulatory) • 03/23/2026 08:16:26 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 03/23/2026 08:13:32 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 03/23/2026 08:11:26 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/12/2026 12:32:00 PM
- Halozyme Appoints David Ramsay as Interim Chief Financial Officer • PR Newswire (US) • 03/12/2026 12:30:00 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 03/10/2026 08:05:17 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 03/09/2026 08:18:04 PM
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- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/04/2026 11:56:16 PM
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- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/24/2026 11:19:02 PM
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- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/17/2026 11:53:47 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/17/2026 11:52:46 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/17/2026 11:51:29 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/17/2026 09:04:55 PM
- HALOZYME REPORTS FULL YEAR 2025 RECORD REVENUE OF $1.4 BILLION AND REITERATES STRONG 2026 FINANCIAL GUIDANCE • PR Newswire (US) • 02/17/2026 09:01:00 PM
