Allstocks.com's Bulletin Board Post A Reply
my profile login | register | search | faq | forum home

» Allstocks.com's Bulletin Board » NASDAQ, AMEX, NYSE Stocks » SYN Synthetic Biologics Inc. » Post A Reply

Post A Reply
Login Name:
Password:
Message Icon: Icon 1     Icon 2     Icon 3     Icon 4     Icon 5     Icon 6     Icon 7    
Icon 8     Icon 9     Icon 10     Icon 11     Icon 12     Icon 13     Icon 14    
Message:

HTML is not enabled.
UBB Code™ is enabled.

 

Instant Graemlins Instant UBB Code™
Smile   Frown   Embarrassed   Big Grin   Wink   Razz  
Cool   Roll Eyes   Mad   Eek!   Confused   BadOne  
Good Luck   More Crap   Wall Bang   Were Up   Were Down    
Insert URL Hyperlink - UBB Code™   Insert Email Address - UBB Code™
Bold - UBB Code™   Italics - UBB Code™
Quote - UBB Code™   Code Tag - UBB Code™
List Start - UBB Code™   List Item - UBB Code™
List End - UBB Code™   Image - UBB Code™

What is UBB Code™?
Options


Disable Graemlins in this post.


 


T O P I C     R E V I E W
BooDog  - posted
from apollo1452

Confidence of SYN-004 gaining FDA approval is rapidly increasing. Riley stated that SYN-004 Phase 2a clinical trial will begin within 2 weeks, March 2015. Trimesta may be "sexy" but SYN-004 is going to do a lot of heavy lifting for the pps IMO.

"The PK data confirmed that SYN-004 acts as Synthetic Biologics intended. SYN-004 goes directly to the gut where intravenous (IV) antibiotics are excreted, with the intention of protecting the microbiome from a cascading set of events that often lead to potentially deadly C. difficile infections,"

"No clinically significant safety events were observed, and both the single and multiple doses of SYN-004 were well tolerated by the participants of the Phase 1 studies"

"No meaningful levels of SYN-004 were observed in the bloodstream after participants received multiple doses of SYN-004 four times a day over a seven-day period." We now have the answer to the big question about SYN-004 being confined to the intestinal tract, that is Huge.

A successful Phase II and beyond for SYN-04 is as much of a "sure thing" as one can hope to find in the risky world of biotech investing IMO. There is also the benefit of these trials moving along at a speedy pace. Riley is doing a good job of managing the process. The relationship between antibiotics and C difficile infections is already very well established. Since SYN-004 is safe & blocking the antibiotics only in the intestinal tract as intended it seems to me that a boatload of derisking has occurred.

Phase 2b (Proof of Concept) trial goals: Demonstrate SYN-004 efficacy at preventing CDAD following IV ceftriaxone & limiting disruption of the gut microbiome by IV ceftriaxone. SYN needs a big enough trial to achieve statistical significance given the rate of c-diff following IV antibiotic therapy. The FDA will want to see a decrease in c. dif rates between those who get SYN-004 plus antibiotic and those who get a placebo plus antibiotic. Riley has been quite clear that this is the approval strategy that SYN has chosen.

Recall the successful Finnish Phase 1 & Phase 2 clinical trials already conducted in the EU. We already KNOW that SYN-004 works as advertised. What an advantage for Riley & Co when designing their strategy for gaining approval from the FDA. It's like being given the answers prior to your big final exam. SYN-004 is a Slam Dunk. GLTL!

====================================

I'll post more of the company info soon but wanted to share this post here. Thought there was a more recent topic on SYN here. I'll try and get here more often. [Wink]
 



Contact Us | Allstocks.com Message Board Home

© 1997 - 2013 Allstocks.com. All rights reserved.

Powered by Infopop Corporation
UBB.classic™ 6.7.2

Share