Replies to post #92444 on Biotech Values

[biomaven0]

Formulation changes made after the Phase 3s.

That's a very good point which has concerned me in general - just one more place for the FDA to pick apart the NDA. I didn't appreciate the potential specific link to their efficacy which you pointed out here though - thanks for that.

You have any thoughts on the competitive program from HALO?

Peter

[genisi]

Too much zigzagging (between India and Ex-India data, 25 IU/cc lyophilized formulation and 100 IU/cc liquid formulation, pH4 and pH7) in this story to make me stay away. Great summary and notes here:

http://siliconinvestor.advfn.com/subject.aspx?subjectid=57918

[mcbio]

Re: BIOD/EDTA

1) The presence of the chelating agent EDTA in Viaject. EDTA is the key to Viaject's ultra fast activity - it chelates the zinc locus where insulin clumps into inactive hexamers. So in Viaject, insulin is in its active monomer form when injected. EDTA is 'GRAS' (generally regarded as safe), but will the FDA have safety concerns over injecting EDTA multple times daily over a patient's entire lifetime?

I realize this post is a bit dated but I just recently started to follow the BIOD story and I assume your concerns still persist. It's not clear to me that the safety issue as it relates to long-term EDTA use was an issued cited by the FDA in its CRL to BIOD. Is this still a concern you see? Also, BIOD has obviously developed, and is going forward with, new formulations though I'm not sure if there are still the long-term EDTA concerns with these new formulations. Anyways, just curious to see if your concerns still persist here and, if so, if you can add any more color as to why you think there would be long-term safety concerns for the use of EDTA, which you noted is otherwise GRAS.