Recent content by hrplz

I received this response 2 weeks ago: Thank you for the email. Information regarding Follica’s clinical program and potential registration will be shared on our website as it becomes available. The studies will also be listed on www.clinicaltrials.gov and will be open to those who meet study...

Still possible they may provide a date - their previous reports were clearly labeled “annual reports” so perhaps something new comes out tomorrow. Guess we’ll know in a little bit.

I think PureTech released their annual report a little early (though it doesn't say "annual report"): https://puretechhealth.com/images/PRTCCorpPresentation.pdf Negatives: nothing really new Positive...ish: still targeting Phase 3 in 2022 (but yes, we've heard this story before)

The PureTech website indicates that Follica has an active IND on file with the FDA. Per the 2016 pdf, the IND was to cover investigational use of a new minoxidil cartridge. It seems that Follica has abandoned the cartridge, so I'm not quite certain what the IND would be for??? Minoxidil plus...

Hi - I was trying to review the (dated) clinical summary document to see if there was anything that might still be relevant and offer insight into timelines (It would have been helpful if they included talking points in their leaked classified document - c'mon, Follica!). It looks like they...

I did my 3rd session last night. Not noticing anything as of yet (but not sure I should be). I use the D2 (1mm, fast) and minoxidil twice per day.

Interesting that this again considers dermabrasion after the 2016 pdf deemed microneedling "just right" compared to DA and MDA (I was also curious what they would do with the RAIN acronym if they were using microneedling...though I guess it's still a possibility that they use microneedling)...

Not sure I am reading this correctly, but p. 22 of the longer pdf seems to suggest that there were 2 sessions for FOL-003: Day 1 - “a non-scarring perturbation” and Day 17-35 - “a more profound perturbation.” Entirely possible I’m misreading this. :)

Yeah, I'm not certain either. In this first go-round, they're using approved drugs. Not sure if combining approved drugs - or combining approved drugs and a device - requires a separate review.

I believe at one point it was mentioned that Follica plans to go the 510(k) route, which is 90 days, for this initial effort. Not sure if that's still the case. 510(k) https://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/510kclearances/default.htm

Are you in the US? How long did it take to deliver? The warnings on their website about USPS were a little crazy (not suggesting USPS is reliable - just seemed strange for a company to phrase it the way they did).

If we go by the Jefferies 2017 chart that Noisette posted on p.7, this could be out by this time next year (assuming the pivotal trial starts immediately after the optimization study). If the red arrows on the chart are somewhat precise, they had the pivotal trial beginning a little after Q1...

Obviously plenty of reasons to be skeptical given all of the delays. Here's my optimistic take with perhaps a tiny bit of realism: 1. They said they would begin an optimization study in the first half of 2018 and that happened. Admittedly, they had to change time frames more than once, but...

While they still say the pivotal trial will start in the first half of 2018, they curiously deleted reference to the optimization study. I think I am going to overanalyze this minor point for the next several days.

Good information - thank you!