[quote][postedby]Originally Posted by roger_that[/postedby]
OK, don’t overreact, jarjar, actually I have great respect for Dr. Naughton who is an excellent CEO from everything I can see, and I think HSC is promising and will probably grow hair – better than Rogaine or Propecia, at least.
The reason I’m posing this question is this issue will have to be answered openly sooner or later, so the sooner we understand what’s going on here, the better.
My reading of all this is that because Histogen is packaging their application as a “2 session protocol”, the implication will be that 2 sessions will actually be all a doctor is permitted to offer to one patient – and of course, by extension, all one patient is allowed to have, before assuming risks of side-effects from overuse or chronic use which may make it impermissible to get more than 2 treatments from any doctor or doctors. Personally I believe there may be some kind of tracking system put into place to safeguard against patients getting more than 2 treatments, mainly to reduce any liability for Histogen and especially for doctors.
I think what you said is true, some doctors will offer more than 2 treatments, and I’m also convinced that MANY patients will “doctor shop” to get treatments from multiple doctors. And not only will they want to do this, many, many patients will succeed in doing this, and get a lot more than 2 treatments, because whatever tracking system or safeguards they put into place will be easy to circumvent.
Therefore it might eventually become something where the FDA “turns a blind eye” and pretends not to notice.
Now, I fully realize I’m sounding like the party pooper here with all this negativity.
But I think we have to get this question out in the open and discussed above board early, because we will be facing this issue later, whether we like it or not.
In any event, if all this sounds very weird and improbable to you, well, that’s great but I can’t do anything about that. It may sound completely improbable, but there’s a “first” for everything.
If you think it’s totally unrealistic and stupid for me to predict that there will be some kind of imposed limit on the number of treatments one can get in a certain space of time, just remember that never before has a pharmaceutical hair loss treatment EVER been trialed with limits on the number of successive applications built into the protocol.
It wasn’t done that way for Minoxidil. From the jump, the assumption was ALWAYS that you would just simply use Minoxidil and keep on applying it every day for the rest of your life, if you wanted to keep your hair. And the FDA had no problem with that.
It wasn’t done with Propecia. From the beginning, from the clinical trials, the idea was ALWAYS that you’d take the pills approximately every day for as long as you wanted to, period. And that didn’t bother the FDA or anyone.
So in this regard, HSC is VERY different. If they thought it was OK to administer this stuff every day, every week, every month or whatever, they’d be trialing it in that way.
The fact that they aren’t to me, is kind of a red flag. Not insofar as it won’t work (I think it will work). But it’s just another complication we may have to face if, for instance, it works well in the first 2 treatments, but not nearly enough to be a massive cosmetic improvement, and then people are told that they can’t get more because the safety of more treatments has not been verified.
Call me stupid, naive, an idiot, or whatever you want to call me, but I believe this will be an issue.
All the more reason that research into other hair loss treatments, like Sanford-Burnham, etc., has to be kept going, and we shouldn’t put all our eggs in one basket with Histogen in the short-term or medium-term.
The ultimate cure will be a live-cell based treatment.[/quote]
Roger_that, how would you compare HSC with Botox injection for wrinkles as far as dosing is concerned?
