BOT

1.33%

37.0¢ botanix pharmaceuticals ltd

Ann: BTX 1503 Acne Phase 2 Study Results Presentation, page-404

First 404 Last

Share
Profile

Follow
Hingdog

23,151 Posts.

1439

24/10/19

01:31

Post #: 41041727
Share

Originally posted by Southoz ↑

Not exactly. As a first step have a read through the FDA guidance for acne trials to understand the issues.

https://www.fda.gov/media/71152/download

The key design issue is that methodologically from the analysis of absolute lesion number change or percent lesion change clinical significance just doesn’t magically pop out.

So the FDA turns the question upside down.

Success or failure is defined by IGA change (2 points) which represents clinically significant improvement. With the quantitative lesion count providing the magnitude of change.

But clinical significance is the first key … because the FDA believe drugs shouldn’t be approved just because they help things … but rather that help needs to be clinically significant.

There is a big long complicated history to why the FDA thinks the way they do about this. .

But in brief the IGA operates like the Clinical Global Impressions (CGI) scale that is commonly used in neuroscience.

Here for example you might improve 3 points on a memory test. But what that means in the real world is highly unclear.

So the FDA promotes the CGI scale as a co-primary to the memory test .… where it wants a clinician to actually qualitatively make a judgment that this change in memory score has made a real world difference …the person can get to the shops and home again now where as before they couldn’t and this has led to a major improvement in quality of life.

All very complicated.

Keeping it simple … would you sign up to a treatment that produces clinical significant improvement in less than 10% of people.

If you had a daughter with Retts disease quite possibly … because there are no other treatments and we are talking about life and death. But not for acne treatment where there are more effective options; defined as higher percentages of people showing two or more point improvement on the IGA.

But that’s it for me for a while … back to trying make difference in the real world myself.

Expand

Here is the IGA success for the recently FDA approved Foamix FMX101. The results look to me(a mug punter) be in line with BTX1503 Australian results?

BOT Price at posting: 12.5¢ Sentiment: None Disclosure: Held
11 Upvote

4 Great analysis

Reply

Top Stories

ASX Market Open: ASX200 to rise for Friday session | July 26

NVA

Nova locks in NASDAQ US market listing at a value of only US$3.3M as ASX gets quieter and quieter

Capital raisings wrap: Brainchip, Ovanti, Lake and VHM

Nine's staff strike as Paris Olympic coverage begins

TRP

Tissue Repairs soars nearly 32% on TGA approval for wound healing gel

HRZ

Horizon firms up ore reserve for Boorara ahead of FY25 Q1 development decision

IGO

IGO kicks off earn-in copper drilling on-site Encounter's Yeneena play as it adopts new identity

MIN

MinRes jumps 5% as the company meets production guidance – depressed iron ore prices be damned

RHK

Red Hawk upgrades Blacksmith with DSO mineral resource at the Eagle Deposit

MND

Monadelphous inks $200M contract with Woodside to help build Pluto LNG – but will it make Scarborough cheaper?

There are more pages in this discussion • 247 more messages in this thread...

First 404 Last

Add BOT (ASX) to my watchlist

(20min delay)
Last 37.0¢		Change -0.005(1.33%)		Mkt cap ! $669.7M

Open	High	Low	Value	Volume
37.5¢	39.0¢	37.0¢	$1.603M	4.223M

Buyers (Bids)

No.	Vol.	Price($)
4	378157	37.0¢

Sellers (Offers)

Price($)	Vol.	No.
37.5¢	98000	5

View Market Depth

No.	Vol.	Price($)
3	243022	0.370
2	310000	0.365
11	672249	0.360
13	763020	0.355
26	466319	0.350

Price($)	Vol.	No.
0.375	65000	3
0.380	110000	1
0.385	138158	3
0.390	716162	7
0.395	520775	8

Last trade - 16.10pm 26/07/2024 (20 minute delay)

BOT (ASX) Chart

Ann: BTX 1503 Acne Phase 2 Study Results Presentation, page-404

ASX Market Open: ASX200 to rise for Friday session | July 26

Nova locks in NASDAQ US market listing at a value of only US$3.3M as ASX gets quieter and quieter

Capital raisings wrap: Brainchip, Ovanti, Lake and VHM

Nine's staff strike as Paris Olympic coverage begins

Tissue Repairs soars nearly 32% on TGA approval for wound healing gel

Horizon firms up ore reserve for Boorara ahead of FY25 Q1 development decision

IGO kicks off earn-in copper drilling on-site Encounter's Yeneena play as it adopts new identity

MinRes jumps 5% as the company meets production guidance – depressed iron ore prices be damned

Red Hawk upgrades Blacksmith with DSO mineral resource at the Eagle Deposit

Monadelphous inks $200M contract with Woodside to help build Pluto LNG – but will it make Scarborough cheaper?

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News

Ann: BTX 1503 Acne Phase 2 Study Results Presentation, page-404

Top Stories

ASX Market Open: ASX200 to rise for Friday session | July 26

Nova locks in NASDAQ US market listing at a value of only US$3.3M as ASX gets quieter and quieter

Capital raisings wrap: Brainchip, Ovanti, Lake and VHM

Nine's staff strike as Paris Olympic coverage begins

Tissue Repairs soars nearly 32% on TGA approval for wound healing gel

Horizon firms up ore reserve for Boorara ahead of FY25 Q1 development decision

IGO kicks off earn-in copper drilling on-site Encounter's Yeneena play as it adopts new identity

MinRes jumps 5% as the company meets production guidance – depressed iron ore prices be damned

Red Hawk upgrades Blacksmith with DSO mineral resource at the Eagle Deposit

Monadelphous inks $200M contract with Woodside to help build Pluto LNG – but will it make Scarborough cheaper?

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News