Frequency Therapeutics — Hearing Loss Regeneration

[Diesel]

Ah. Yes. I expect Lucchino to make the announcement right before the presentation but not at the presentation. But just a guess.

I could see this happening also.

It's possible it could be a PR that discusses really broad positive top-line out, then promises a presentation with details to follow.

 

[FGG]

Considering that it was Trump who opened up Compassionate Use, I doubt Biden's new FDA head will be willing to break down bloated FDA regulations.

It was also Trump's head of the FDA that said last year that regulation reform is needed. Of course haven't seen any action taken to backup that sentiment...

It seems like Biden more or less wants to do the opposite of what Trump did. So if Trump made access a little easier, I'd imagine Biden's pick will ultimately make it harder. The Executive Order that affected insulin is a good example of this.

I could be wrong though, and I hope I am!

Eh... considering the person in the running most likely to get the nomination has for years been fighting for FDA reform (Woodcock), I don't think that's the case.

She might not get it, though, because some groups blame her for the approval of new opioids during the opioid epidemic but she generally has a history of wanting faster drugs approval for patients (and actually has met with patient advocacy groups in the past) and I would view it favorably for serious, unmet need drugs especially if she gets the nod.

The other likely choice is Sharfstein, who is much more conservative with the drug approval process.

But investors at least want to know who the nominee will be so they can plan accordingly.

 

[Diesel]

Eh... considering the person in the running most likely to get the nomination has for years been fighting for FDA reform (Woodcock), I don't think that's the case.

She might not get it, though, because some groups blame her for the approval of new opioids during the opioid epidemic but she generally has a history of wanting faster drugs approval for patients (and actually has met with patient advocacy groups in the past) and I would view it favorably for serious, unmet need drugs especially if she gets the nod.

The other likely choice is Sharfstein, who is much more conservative with the drug approval process.

But investors at least want to know who the nominee will be so they can plan accordingly.

I don't mean to derail. The Federal "Right to Try" laws signed by Trump didn't do anything to reform the FDA. What it may do is lessen the FDA's ability to enforce. The last reform of the FDA, where the term "reform" means that the actual internal functions / processes of the FDA are changed, occurred under Obama and led to the Breakthrough Therapy Designation.

If any additional reform takes place under Biden's watch, it will be something along the lines of the Promising Pathway Act, that gives the FDA the ability to permit pharmaceutical companies the ability to treat patients with highly safe drugs in parallel to a Phase 3/pivotal trial. The reason I think this is because Biden, even as VP under Obama, was an advocate for providing / accelerating the development of advanced treatments for rapidly progressing / terminal diseases and cancers.

Parallel Pathway Act would certainly be favorable for those seeking to gain access to FX-322 as it "fits" the current indication outlined in the bill. However, FX-322 is probably far enough along that the Promising Pathway Act won't have any benefit.

TL;DR: Trump didn't reform the FDA. He "defanged" it with the pen by giving drug makers a shortcut.

 

[Aaron91]

I don't mean to derail. The Federal "Right to Try" laws signed by Trump didn't do anything to reform the FDA. What it may do is lessen the FDA's ability to enforce. The last reform of the FDA, where the term "reform" means that the actual internal functions / processes of the FDA are changed, occurred under Obama and led to the Breakthrough Therapy Designation.

If any additional reform takes place under Biden's watch, it will be something along the lines of the Promising Pathway Act, that gives the FDA the ability to permit pharmaceutical companies the ability to treat patients with highly safe drugs in parallel to a Phase 3/pivotal trial. The reason I think this is because Biden, even as VP under Obama, was an advocate for providing / accelerating the development of advanced treatments for rapidly progressing / terminal diseases and cancers.

Parallel Pathway Act would certainly be favorable for those seeking to gain access to FX-322 as it "fits" the current indication outlined in the bill. However, FX-322 is probably far enough along that the Promising Pathway Act won't have any benefit.

TL;DR: Trump didn't reform the FDA. He "defanged" it with the pen by giving drug makers a shortcut.

Looking at this simply from a human perspective and not so much a political perspective, you would think having already lost his own son to brain cancer that Biden would be inclined to introduce policies that could reduce the chances of others having to incur a similar heartbreaking loss.

 

[RichieTheKid]

I truly hope with all my soul this drug is successful because I need it and so does everyone here, even if it's just a little relief that's a huge step.

 

[Diesel]

Just a thought. The FX-322 Phase 1B for Age-Related Hearing Loss is likely to be completed this month as well. 3 months from its Active date is 3/17.

It's possible they may be waiting for timing a top-line readout, or adding a mention of its completion of that trial as well.

I'm not sure we're all going to be able to handle this much data coming out in 1 year.

You guys ready for this?

 

[Gb3]

Guess Bobby isn't in the loop.

 

[Zugzug]

I'm not sure we're all going to be able to handle this much data coming out in 1 year.

You guys ready for this?

I was born ready for this.

Quite literally, I was born with LGR5+ progenitor cells, waiting for Will McLean to figure out that they could activate, divide, and produce new hair cells. I was also born with an intestine and paneth cells for Xaiolei Yin to discover as the action behind my intestines regenerating.

Glasses are on. Calculator has fresh batteries. Let's do this, Diesel. May you fuel us all with the knowledge and energy to carry this out properly. Everyone turn on your WNT and notch pathways; this will be a long stretch.

 

[Aaron91]

You guys ready for this?

 

[Rubenslash]

After following this thread and company for more than 4 years, we will finally get the answers in the coming weeks. It's exciting for sure.

 

[ZaneBerry]

I try not to get my hopes up too much but...

 

[Ed209]

but my overwhelming preference is to buy early and hold.

This has always been the best strategy. Trading is more like gambling and most people lose money.

 

[Zugzug]

View attachment 43866

 

[AtlasFainted]

Eh... considering the person in the running most likely to get the nomination has for years been fighting for FDA reform (Woodcock), I don't think that's the case.

She might not get it, though, because some groups blame her for the approval of new opioids during the opioid epidemic but she generally has a history of wanting faster drugs approval for patients (and actually has met with patient advocacy groups in the past) and I would view it favorably for serious, unmet need drugs especially if she gets the nod.

The other likely choice is Sharfstein, who is much more conservative with the drug approval process.

But investors at least want to know who the nominee will be so they can plan accordingly.

I hope Woodcock takes it then! Less regulation is better in my book.

 

[patorjk]

Guess Bobby isn't in the loop.

The price targets for this stock always seem really random. Before the trial was pushed back, I saw year-out targets of around $40 a share when the stock was sub-$20. These estimates seemed way off, especially considering the potential of this drug. I wonder if these analysts just have so many stocks they need to watch that they don't fully comprehend the value of FX-322. Or maybe they just want to be cautious?

As an interesting preview of where we may land post-Phase 2a results, back on February 22 Frequency Therapeutics posted on their website (after the closing bell) a paper for the Phase 1/2 results. The title of the press release was positive and could easily be mistaken for the publishing of the Phase 2a results. The stock briefly shot up to $88 a share in after-hours trading, before going back to normal. My guess is that's where we'll start if the results are positive.

 

[MrCrybaby]

I was born ready for this.

Quite literally, I was born with LGR5+ progenitor cells, waiting for Will McLean to figure out that they could activate, divide, and produce new hair cells. I was also born with an intestine and paneth cells for Xaiolei Yin to discover as the action behind my intestines regenerating.

Glasses are on. Calculator has fresh batteries. Let's do this, Diesel. May you fuel us all with the knowledge and energy to carry this out properly. Everyone turn on your WNT and notch pathways; this will be a long stretch.

All I WNT is for my tinnitus and hyperacusis experience to be nothing but a notch in the belt that is my life

 

[Guywithapug]

 

[Aaron91]

View attachment 43868

 

[Zugzug]

View attachment 43872

I haven't had this much fun in... years?

 

[Koz]

Know your worth KINGS (and Queens).

 

[Diesel]

You've reached new heights as a therapeutic company when memes about your experimental drug start showing up in Google images.

 

[Diesel]

Oh hey, the investors site is down at frequencytx.com... wonder... if... they're... making... an... update.

 

[Aaron91]

View attachment 43874

I haven't had this much fun in... years?

 

[Keith Handy]

I guess it's meme season?

 

[Diesel]

 

[Aaron91]

 

[Zugzug]

View attachment 43877

I'm done meme-ing back, as I don't want to kill it. Aaron, what I think is so funny about your meme is that this how everyone feels when they post a theory -- like a regular person just trying their best, mispronouncing the scientific terms.

 

[serendipity1996]

I guess it's meme season?

View attachment 43878

You should include Michael Leigh along with the ENTs and audiologists haha.

 

[Koz]

Okay one last one...

View attachment 43877

 

[Jcmc]

View attachment 43868

I guess they just need a higher dose of FX-322 and using low frequency sounds to reach the apex of the cochlea.