Answers - Finance

The weekly TradeTech uranium spot price indicator remained unchanged for a third straight week, but Tuesday’s sale of 100,000 pou

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

nds U3O8 could result in another record price spurt. According to Nuclear Market Review (NMR) editor Treva Klingbiel, “This lot o

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

material represents an opportunity for buyers to secure material at a fixed price and is expected to be highly sought after.”

I

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

's been two months since the last uranium auction. That one led to a record price jump in yellowcake. How will this auction compa

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

e? It could be an eye-opener.

Klingbiel pointed out in the February 16th issue of NMR, “The majority of other supply currently a

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ailable to potential buyers is being offered with market-related pricing terms at time of delivery.” Utilities and other buyers h

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

sitate to accept U3O8 and related product under these terms. As a result, the spot uranium price has remained nearly unchanged fo

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

the past two months, aside from a small percentage increase at the end of January.

Activity has come to a standstill at these l

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

fty price levels. Uncertainty about remediation efforts by Cameco Corp at its Cigar Lake uranium project has left buyers and sell

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

rs at odds with each other. As TradeTech has told us during this two-month stalemate, buyers are nervous about paying these price

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

, while sellers are confident they can get even higher prices. Three weeks before the Cigar Lake flood, we reported that some uti

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ities believed the uranium price would decline to $30/pound. By mid December, the price had jumped another 50 percent above Octob

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

r’s high levels.

The significant problem buyers now face is being forced to blindly agree to purchase uranium without knowing th

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

final price tag. Contracts for the sale of uranium lack a fixed price. Because contracts are written under ‘market-related prici

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

g terms,’ U.S. utilities and others would never really know the final cost of their purchase until months later, when the product

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

would be delivered. Buyers might worry the final price tag could be many percentage points higher than what they believed they mi

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ht be paying.

In light of these market conditions, we believe the modest sale of 100,000 pounds U3O8 would likely result in a ne

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

record spot uranium price. Treva Klingbiel is accurate in her forecast for the February 20th auction – this uranium should be hi

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

hly sought after. Numerous crystal ball gazers have predicted the spot uranium price should reach $80/pound after the sealed bids

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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