Replies to post #185938 on Biotech Values

[tpizzazz24]

That's good to know. I imagine that the level of wound care would be impeccable, cutting down on the risk of infection. I wouldn't of thought that. Thanks for your insight bioM

[DewDiligence]

Re: MCUR /diabetic foot ulcers

Genaera (when it was known as Magainin Pharmaceuticals) was one such case. Its failure in a diabetic foot ulcer trial nearly forced the company into bankruptcy.

Still, such companies as MCUR can make attractive picks for the SI charity contest (#msg-109625174).)

[DewDiligence]

DPRX is trying to get Locilex approved for diabetic foot ulcers:

http://www.lifescienceleader.com/doc/does-a-full-room-at-bio-ceo-indicate-a-company-past-its-tipping-point-0001

Yes, this is the same Locilex that was rejected by FDA and almost forced Genaera into bankruptcy in 2002 (until GENR changed stripes and became an AMD/cancer company with Squalamine). DPRX says there was never any problem with the drug, but rather with the manufacturing, which has now allegedly been fixed.

Sometimes, retread programs actually work out. Among the stocks I own, CNAT is attempting such a comeback story. However, I wouldn't make a habit of investing in these kinds of programs.

[DewDiligence]

(DSCI)—Over the years I have saved a lot of money by never investing in any diabetic ulcer treatment… Likely some day I will be proved wrong and some drug or treatment will actually work in a trial, but not a bet I am ever prepared to take.

As of today, the futility streak in this indication remains intact (#msg-118440261, #msg-118037828).

[DewDiligence]

Re: Diabetic foot ulcers

Likely some day I will be proved wrong and some drug or treatment will actually work in a trial, but not a bet I am ever prepared to take.

FDA just approved the PMA for Sanuwave’s Dermapace System, which uses shock waves to treat the wounds:

https://www.prnewswire.com/news-releases/fda-permits-marketing-of-device-to-treat-diabetic-foot-ulcers-300575883.html

The FDA reviewed clinical data from two multi-center, randomized, double-blind studies with a total of 336 diabetic patients receiving either usual care, which includes wet-to-dry dressings or debridement (removal of damaged tissue) as needed, plus the Dermapace System shock wave therapy or usual care plus non-working (sham) shock wave therapy.

The patients who had between one and seven treatments with the Dermapace System showed an increase in wound healing at 24 weeks with a 44 percent wound closure rate. Those patients treated with the sham shock wave therapy showed a 30 percent wound closure rate during the same time period.

The above sounds like a non-ITT comparison, but this is a press release from the FDA itself!