Where we at?, page-680

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.