Australia's largest stock trading and investment forum Australia's #1 stock forum

PAR

Click for more information

7.69%

21.0¢ paradigm biopharmaceuticals limited..

Where we at?, page-706

First 706 Last

Share
Profile

Follow
m931392

120 Posts.

10

12/07/24

02:09

Post #: 74717603
Share

Originally posted by Gan_Gans: ↑

........."These dataprovide a detailed justification for the clinical development for
iPPS with the dosing regimen of 2 mg/kg twice weekly for 6 weeks of initial therapy."

.......

"The key items addressed in the Type D response submission to the FDA include:
• The minimal effective dose justification.
•Additional nonclinical studies completed to GLP standards to address previously
noted adrenal findings.
• Draft clinical trial protocol.
•Revised safety monitoring and mitigation plan.

Subject to FDA clearance, Paradigm intends to promptly move forward with subject
enrolment into the phase 3 clinical trial (PARA_OA_012) in 2H CY2024......"

2 mg/kg has never been cleared by the FDA. If it was, you can bet your bottom dollar that 2 mg/kg would have been in the dosing study to generate comparable data. Even you would do that.

BTW - you don't submit a new IND, on top of an IND for the same investigation...

MPS trial - failed with no hope of a partner.
Dosing study for OA - failed or as Donna Skerett put it "Did not meet the required performance thresehold"

Expand

Will be interesting to see if PR addresses the clinical hold, adrenal findings, and 2 mg/kg dosage at the Biotech Summit

PAR Price at posting: 27.5¢ Sentiment: Sell Disclosure: Held
Upvote

0 Great analysis

Reply

Top Stories

OCT

Octava Minerals joins the antimony train with high-grades on the radar at Yallagong, WA

ARV

Smallcap Artemis Res' jumps 23% on six digit gold grade rockchip find at Titan

ARB

Court process clears way for ARB to buy up 4 Wheel Parts business in the US

Tonight's US CPI data could set the tone for November. What are markets expecting?

IMA

Issues emerging as Australian companies tackle critical minerals challenge

There are more pages in this discussion • 1 more message in this thread...

First 706 Last

Add PAR (ASX) to my watchlist

(20min delay)
Last 21.0¢		Change 0.015(7.69%)		Mkt cap ! $73.55M

Open	High	Low	Value	Volume
20.5¢	21.0¢	20.0¢	$216.0K	1.057M

Buyers (Bids)

No.	Vol.	Price($)
8	143324	20.0¢

Sellers (Offers)

Price($)	Vol.	No.
21.0¢	44935	3

View Market Depth

No.	Vol.	Price($)
7	138349	0.200
9	191984	0.195
15	199884	0.190
6	161140	0.185
16	784128	0.180

Price($)	Vol.	No.
0.210	44935	3
0.215	132157	4
0.220	82155	7
0.225	31604	3
0.230	33834	4

Last trade - 16.10pm 10/10/2024 (20 minute delay)

PAR (ASX) Chart

SPONSORED BY