![](http://investorshub.advfn.com/images/default_ih_profile2_4848.jpg?cb=0)
Monday, May 18, 2015 4:52:00 AM
One big downside to TheraSphere is that it is NOT biodegradable[1]. That is a huge concern because how would the body remove it? Is there a danger of accumulation? What happens if there is an accumulation?
The fact that TheraSphere is NOT biodegradable separates it from SIR-Sphere and Radiogel. But I can't comment any further on SIR-Sphere and Radiogel because I don't know what polymers it's made of. The formulation of the polymer composite matrix is probably considered reasonably different than the resin used for SIR-Sphere although function is probably still about the same. And now it comes down to cost. All of the things mentioned above.
So in my opinion, would this get FDA approval? Very likely. There is no reason why SIR-Sphere would be approved and Radiogel won't be especially if ADMD can demonstrate to the FDA that the matrix it uses can hold up and is biocompatible with the body. At the end of the day, SIR-Sphere and Radiogel are probably doing the same thing with reasonably close efficacy and safety levels. Think MSFT vs AAPL sort of competition.
[1] http://www.accessdata.fda.gov/cdrh_docs/pdf/H980006b.pdf
Recent RDGL News
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/13/2024 05:58:27 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/13/2024 05:56:22 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/07/2024 05:26:33 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/02/2024 01:00:03 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/29/2024 05:16:12 PM
- Form QUALIF - Notice of Qualification [Regulation A] • Edgar (US Regulatory) • 07/17/2024 04:15:04 AM
- Form 1-A/A - Offering Statement [Regulation A]: [Amend] • Edgar (US Regulatory) • 07/15/2024 10:02:55 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/04/2024 06:28:50 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/09/2024 09:30:31 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/27/2023 09:40:48 PM
- Form 1-A POS - • Edgar (US Regulatory) • 11/27/2023 10:29:12 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/06/2023 04:28:46 PM
- Form 1-A POS - • Edgar (US Regulatory) • 11/03/2023 09:03:20 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/19/2023 04:18:34 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/11/2023 10:33:58 AM
- Form 1-A POS - • Edgar (US Regulatory) • 10/10/2023 04:05:36 PM
Alliance Creative Group (ACGX) Releases Q2 2024 Financial and Disclosure Report with an increase of over $130,000 in Net Income from Q2 2023 to Q2 2024 • ACGX • Aug 14, 2024 8:30 AM
Avant Technologies Unveils AI-Powered Healthcare Infrastructure to Deliver Intelligent Healthcare Solutions • AVAI • Aug 14, 2024 8:00 AM
SANUWAVE Announces Record Quarterly Revenues: Q2 FY2024 Financial Results • SNWV • Aug 13, 2024 7:11 AM
Kona Gold Beverages, Inc. Nears Completion of Reverse Merger with New Candidate • KGKG • Aug 12, 2024 10:00 AM
Maybacks Global Entertainment and DigiTrax Entertainment Sign Agreement to Broadcast "Karaoke Cloud" on iDreamCTV • AHRO • Aug 12, 2024 8:45 AM
HealthLynked Partners with RxSpark to Enhance Medication Access and Management for Patients • HLYK • Aug 12, 2024 8:00 AM