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Biotech / Medical : Repligen Corp (RGEN) -- Ignore unavailable to you. Want to Upgrade?

To: Cheryl Galt who wrote (194)	12/8/1999 10:38:00 PM
From: Cheryl Galt	Respond to of 395

The NEJM article is accompanied by a cautionary-tale, axe-to-grind editorial ... nejm.org The other (UC-Irvine) extremely small, non-targeted cross-over study published on Medscape Friday Oct 8 medscape.com was likewise designed to squelch the black market and the widespread, uncontrolled, web-inspired experimentation. But that "study" received almost no press, and seemed not to affect the stock. IMO, with so many 8-week, single dose trials with various agendas terminating this winter or generating preliminary data, this down day was an accident waiting to happen. --------------- Disclosure. I like this company, got out first thing Monday morning October 11, have been watching it closely, will re-enter ... Meanwhile, parents will continue to experiment. And soon -- with expedited, orphan status -- Repligen's tested product will be available to them, kill that black market, and earn revenue for the company (plus ChiRhoClin, that started working on both porcine and synthetic human Secretin when Ferring dropped out). IMO, Herlihy has a remarkably solid strategy -- and if Secretin can help a subset of patients, he'll bring it through. And, after all, isn't Secretin actually a potential serendipidous frosting on the Repligen cake? Herlihy has said from the start that Secretin (like insulin) would likely need multiple doses. A few weeks ago, he put a good guide on his website, for evaluating bias in clinical trials. Good reading, for newbies like me. Looking forward to the real trials ... Cheryl PS -- speaking of heart, i suppose it's common knowledge that Herlihy has two daughters with autism. Off soapbox ...

To: Cheryl Galt who wrote (194)	12/8/1999 11:09:00 PM
From: LLCF	Respond to of 395

<Methods. We conducted a double-blind, placebo-controlled trial of a single intravenous dose of synthetic human secretin in 60 children (age, 3 to 14 years) with autism or pervasive developmental disorder. The children were randomly assigned to treatment with an intravenous infusion of synthetic human secretin (0.4 æg per kilogram of body weight) or saline placebo. We used standardized behavioral measures of the primary and secondary features of autism, including the Autism Behavior Checklist, to assess the degree of impairment at base line and over the course of a four-week period after treatment. > This sounds like the North Carolina [?] study... look at the age spans... hope the company doesn't do this. Lots of evidence to suggest gut problems brought on by a variety of factors resulting in Candida overgrowth spinning off neuro-toxins. Speculation that over the long term brain damage may be done, so better digestion and other positive impacts of secretin wouldn't have nearly the desired effect on older patients. I would do 3-5 year olds... 2 or 2 1/2 if possible, although most 'autism experts' wont diagnose till 3 :(. Also, I'd absolutely LOVE to know about the follow up observations, 1/2 the time doctors tell parents their kids are fine for months and months because of their limited observational data. The fact the the parents wanted to continue is interesting. A typical doctor [sorry docs] will say that's because they'll grasp at anything... this is not my experience. So over the 4 weeks how many obervations did they make and for what time period? DAK