Dr Bhanusali Instagram Post - Follica Associate

Jay2016

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Hey Guys,

I follow Dr Bhanusali on instagram, he has put a few things about Follica in the past. Anyways, today he posted a picture which talks about clinical trials - maybe Follica are finally close to running their pivotal trial?
 

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Left4bald

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hi there
Have you seen this on the doctor's website ?

Hair loss

Utilizing the latest cutting edge techniques, Dr. Bhanusali has crafter various treatment modalties for both female and male hairloss. After undergoing lab testing to determine any medical causes for hairloss, Dr. Bhanusali utilizes a patient specific treatment regimen to obtain impressive results


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Janks16

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There's nothing specific in the wording above. Hopefully they'll clarify with some details. Very curious about this one.
 

PeggyPeterson

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There’s a liklihood that the clinical trials he is referring to aren’t necessarily relates to Follica. (-: he’s in NY no? Maybe someone could ask him in a consult
 

hanginginthewire

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There’s a liklihood that the clinical trials he is referring to aren’t necessarily relates to Follica. (-: he’s in NY no? Maybe someone could ask him in a consult

Maybe he could have clarified in his post? It’s obvious he’s just trying to hype his office up. Thus no details. These people don’t mind dangling carrots in front of people who are suffering - so long as they can make a buck. Doesn’t bode well for Follica.
 

Kagaho

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Nice. I too think he is referring to Follica, its consistent with the timeline and it was known they will pursue FDA Clearance for the device rather than FDA Approval.

Thats why Bhanusali is going to trial the device in his clinic.
 

PeggyPeterson

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@hanginginthewire That is a possible explanation, but neither of us know for sure what’s on his mind. He could be a sneaky dude trying to get people into his clinic, or he could be genuinely wanting this Follica thing to work out (if that’s even what he is talking about). Or it could be a bit of both.

You’re comment seems a tad slanderous unless you have information we don’t know about this particular person? Were you his patient? Has he been convicted of fraud?
 

PeggyPeterson

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Nice. I too think he is referring to Follica, its consistent with the timeline and it was known they will pursue FDA Clearance for the device rather than FDA Approval.

Thats why Bhanusali is going to trial the device in his clinic.

FDA cleared devices are ones that is “determined to be substantially equivalent to an already marketed device”

This isn’t really good news in my opinion. You’d want FDA approval over Clearance. Where did you hear about this? It’s rather difficult to discern official information from hearsay

So the clearance might be for their “similar” version of microneedling, which does seems to work quite well as an adjunct therapy.
 

hanginginthewire

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@hanginginthewire That is a possible explanation, but neither of us know for sure what’s on his mind. He could be a sneaky dude trying to get people into his clinic, or he could be genuinely wanting this Follica thing to work out (if that’s even what he is talking about). Or it could be a bit of both.

You’re comment seems a tad slanderous unless you have information we don’t know about this particular person? Were you his patient? Has he been convicted of fraud?

I’ve never been a patient of Giovanni Brotzu either. I can put 2 and 2 together, that’s all.
 

Kagaho

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FDA cleared devices are ones that is “determined to be substantially equivalent to an already marketed device”

This isn’t really good news in my opinion. You’d want FDA approval over Clearance. Where did you hear about this? It’s rather difficult to discern official information from hearsay

So the clearance might be for their “similar” version of microneedling, which does seems to work quite well as an adjunct therapy.

They said that at their anual meeting in 2017. Dont know if you can find that info though. Maybe digging up some old threads here about Follica

Its pretty simple, they dont need a full phase 3 trial for the first iteration of their product. But we know they are developing their own compounds that will improve their product and those will follow the "classic" approval pathway for drugs.

It would be interesting to know if Bhanusali recruiting is for the optimisation trial or the upcoming Pivotal.
 
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