Where we at?, page-683

First 683 Last

Share
Profile

Follow
elquottro

121 Posts.

31

08/07/24

16:37

Post #: 74658189
Share
Originally posted by Gan_Gans: ↑

The 2 mg/kg dose is under hold by the FDA. There is no other way you can look at it.

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.

Clinical Holds are addressed here: https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-procedures-clinical-hold

Some of the reasons for clinical holds are:

Human subjects are or would be exposed to an unreasonable and significant risk of illness or injury; or
Pharmacology and Toxicology:
Data from animal studies are not sufficient to support the anticipated exposure (dose, route of administration, and duration) for the proposed clinical trial
Poor quality non-GLP toxicology studies with difficult to interpret results and a safety signal that has not been sufficiently studied are proposed as pivotal toxicology studies to support use of the product in humans
Clinical:
Previously observed toxicities of the product are not addressed by the proposed safety assessments in a clinical protocol
For a product with a high potential for an unpredictable acute reaction, all subjects are dosed at the same time without consideration to staggered administration.

Well - hello....sound familiar? Does anyone recall the issues with Elmiron too?

Further:

None of the lower doses generated efficacy. The 1.5 mg twice weekly, had variable results with some endpoints faring worse than PBO. - Back to the FDA Clinical Hold......

The drug has been studied in one or more adequate and well-controlled investigations that strongly suggest lack of effectiveness;

IND submissions are normally 700-800 pages.

TGA Determination was forecasted to be given to PAR in Q2, according to what they said in the last quarterly.

Do you know the poor fund performance of 51 Capital? It is shocking.

Expand

If that is your belief, then why are you here??
Absolutely baffling that you put so much time and energy into something that by your opinion is destined to fail. Why not get out while you still can?
PAR Price at posting: 29.0¢ Sentiment: None Disclosure: Held
12 Upvote

2 Great analysis

Reply

Top Stories

TIG

Tigers Realm's US$49M sale of Russian assets – to a Kremlin-adjacent billionaire – set to go ahead

MKT

The ASX can overlook its Telecomm small-caps. Here’s one diversified brand with an international footprint

NWH

NRW Holdings inks $109M deal with BHP for works at Jimblebar

A3D

Defence MOU for propulsion systems pushes Aurora Lab shares higher

SHN

Sunshine Metals kicks off copper gold drilling at Truncheon; Highway East targets

There are more pages in this discussion • 24 more messages in this thread...

First 683 Last

Add PAR (ASX) to my watchlist

(20min delay)
Last 21.5¢		Change 0.005(2.38%)		Mkt cap ! $75.30M

Open	High	Low	Value	Volume
21.0¢	22.0¢	20.5¢	$158.0K	738.4K

Buyers (Bids)

No.	Vol.	Price($)
7	95003	21.5¢

Sellers (Offers)

Price($)	Vol.	No.
22.0¢	74945	4

View Market Depth

No.	Vol.	Price($)
7	95003	0.215
8	190228	0.210
7	143642	0.205
11	264449	0.200
12	346735	0.195

Price($)	Vol.	No.
0.220	74945	4
0.225	81275	5
0.230	152121	6
0.235	73202	4
0.240	65386	4

Last trade - 13.46pm 11/10/2024 (20 minute delay)

PAR (ASX) Chart

Where we at?, page-683

Tigers Realm's US$49M sale of Russian assets – to a Kremlin-adjacent billionaire – set to go ahead

The ASX can overlook its Telecomm small-caps. Here’s one diversified brand with an international footprint

NRW Holdings inks $109M deal with BHP for works at Jimblebar

Defence MOU for propulsion systems pushes Aurora Lab shares higher

Sunshine Metals kicks off copper gold drilling at Truncheon; Highway East targets

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News

Where we at?, page-683

Top Stories

Tigers Realm's US$49M sale of Russian assets – to a Kremlin-adjacent billionaire – set to go ahead

The ASX can overlook its Telecomm small-caps. Here’s one diversified brand with an international footprint

NRW Holdings inks $109M deal with BHP for works at Jimblebar

Defence MOU for propulsion systems pushes Aurora Lab shares higher

Sunshine Metals kicks off copper gold drilling at Truncheon; Highway East targets

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News