SI
SI
discoversearch

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor.  We ask that you disable ad blocking while on Silicon Investor in the best interests of our community.  If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.
Biotech / Medical : SANGUINE CORP. (SGNC) -- Ignore unavailable to you. Want to Upgrade?


To: R>G> who wrote (3026)7/12/1998 12:45:00 PM
From: Prospector  Read Replies (1) | Respond to of 5402
 
1-6 months : Perform preliminary gross animal tests

6-12 months : Conduct animal safety and efficacy trails. Make strategic Alliance with large pharmaceutical firm.

12-30 months: Simultaneously prepare IND applications for European and United States FDA approvals, revive clinical trails with Italian Red Cross & Health Ministry, Erasmus University, Rotterdam, et,al.

Conduct trials for cardioplegia, cancer and cardiology in United States, but transfusion elsewhere.

30 -33 months: Submit license applications to Italian, Dutch, et, al. Begin production at Subcontractors.

33-36 months : Submit United States New Drug Application (NDA). Begin sales in Italy, Holland and other countries which accept their drug approvals.

36 months Plus: Begin United States & Canada sales for cancer and PTCA. Continue trails on other applications, transplant organ preservation. CO poisoning, sickle cell anemia, stoke and heart attack, et, al.



To: R>G> who wrote (3026)7/12/1998 1:03:00 PM
From: Prospector  Respond to of 5402
 
Sanguine plans to conduct PHER-)2 initial trials off-shore, Which is customary for United States drug manufacturers, since these trials are less expensive and faster to complete. Arrangements have already been made to accomplish this in Europe. The United States FDA concluded that the same Perfluorocarbon (Decalin) red cell substitute used in the United States and Japanese trials is safe for human use. This represents a major regulatory hurdle, although human efficacy of PHER02 in humans must be proved biostatistically. Approvals will also be required in the health ministries in England, France, Germany, Japan, Italy and Spain to open these markets for production penetration, although these will be easier than the U.S.



To: R>G> who wrote (3026)7/12/1998 1:09:00 PM
From: Prospector  Respond to of 5402
 
At key development points of the program, members of the former Alpha Therapeutics research and management team will be brought back on board to handle the clinical trials that must be completed in the United States and offshore. They have the experience in medical, regulatory, manufacturing, marketing, quality assurance and the administration needed to accomplish the process.

Prospector



To: R>G> who wrote (3026)7/12/1998 1:12:00 PM
From: Prospector  Respond to of 5402
 
The Company believes that this team, combined with the information obtained from the Fluosol FDA approval process, will help shorten the approval process required for FHER-02.

Prospector