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FDA presses pause on trial for OTC version of anti-impotence drug…

November 7, 2023 Insurance rx clomid by rosedigby1

By Tassilo Hummel and Natalie Grover

PARIS/LONDON, May 30 (Reuters) – The U.S. health regulator has put on hold a trial designed to evaluate switching the prescription-only erectile dysfunction drug Cialis to an over-the-counter (OTC) treatment, French drugmaker Sanofi said on Monday.

The pause is related to concerns about how the trial protocol has been designed, the company said, adding that no patients had so far been recruited for the study.

Cialis, known chemically as tadalafil, was first approved by the European Medicines Agency in 2002 and then by the U.S. Food and Drug Administration (FDA) in 2003 as a prescription-only therapy.

The treatment – which made developer U.S. drugmaker Eli Lilly billions before can i get generic clomid competition eroded sales – has differentiated itself from competition because it has a time-release formula that allows men to take it anywhere up to 36 hours before they use it.

In 2014, Sanofi won the license to sell Cialis as a non-prescription drug in the United States, Europe, Canada and Australia, once regulatory approvals have been secured in each region.

This OTC version of Cialis is expected to be a key contributor to achieving above-market growth from 2024 in Sanofi’s consumer health division, a company executive said last year.

Any delays here are clearly unhelpful, Bernstein analyst Wimal Kapadia told Reuters, adding that it was unclear what the delay would mean for that 2024 timeline.

Sanofi’s stock was down more than 3% by late morning on Monday.

When determining whether to allow prescription drugs to be sold over the counter, the FDA weighs whether patients are able to understand complex aspects of their condition and exactly when to take the drug to ensure safe use.

Like rival anti-impotence drugs, such as Viagra, Cialis can i get generic clomid cause a dangerous fall in blood pressure if taken with nitrates, a class of heart drugs that include nitroglycerine.

The global erectile dysfunction treatment market was estimated to be worth roughly $3.7 billion last year, and is expected to grow to about $5.9 billion by 2028, according to market intelligence firm Coherant Market Insights, though it was unclear what slice of the market was expected to be taken by OTC drugs. (Reporting by Tassilo Hummel in Paris and Natalie Grover in London; additional reporting by Juliette Portala in Gdansk; Editing by Bradley Perrett and David Holmes)

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Private market gives WeWork shares the cold shoulder

November 7, 2023 Loans rx clomid by clemmieroark

By Joshua Franklin and Anirban Sen

NEW YORK, Oct 15 (Reuters) – Trading in shares of WeWork in the private over-the-counter (OTC) market has almost ground to a halt, underscoring a loss of investor confidence in the office-sharing company and providing further evidence of its recent huge loss in value.

New York-based WeWork two weeks ago abandoned plans for an initial public offering (IPO) in 2019, after potential investors raised concerns about its ballooning losses, whether its business model was sustainable, and the way the company has been managed.

Without an IPO, investors and employees looking to cash out would need to turn to the private market, which is less liquid and more opaque than public markets. Outside of company sanctioned share sales, WeWork shares are not directly tradable because of the terms under which they were issued. However, that has not stopped synthetic versions from being created for the OTC market where to buy generic clomid they would be expected to trade at a modest discount to the estimated price of the actual stock.

That synthetic WeWork stock would currently fetch $20 or less per share, according to one investor who is active in the private market.

That would value the company at around $7 billion based on the 338.4 million shares on issue, an extraordinary decline from the $47 billion valuation it had in January when SoftBank Group Corp last invested through its Vision Fund and from the private market value of $30 billion that one source said was prevailing in June.

But deals even at the much lower price are far from assured.

“We’ve seen zero interest in trading on the secondary market for WeWork. Our understanding is that there has been little, if any, trading in the name more broadly,” said Jane Leung, chief investment officer at Scenic Advisement, a boutique investment bank specializing in private share sales.

Leung said WeWork share trading slowed after the company’s IPO announcement in August and more so after it became clear the IPO was in trouble.

“where to buy generic clomid there is interest, it is mostly institutional investors looking to reduce their positions,” she said.

As well as its major shareholder, Japan’s SoftBank, owners of WeWork stock include many leaders from the venture capital and investment worlds, such as Benchmark Capital, JPMorgan Chase & Co, Goldman Sachs Group Inc, Harvard Management Co and Fidelity Management & Research, according to the Pitchbook database.

WeWork declined to comment on the trading activity of its shares in the private market.

STRUGGLING TO SELL

Estimates of WeWork’s value had fallen to as low as $10 billion to $12 billion around the time that it decided to abandon the IPO, Reuters reported last month.

Now, though, a number of current investors in the office-sharing startup are struggling to sell shares, according to two investors who are active in private markets.

One investor was looking to sell shares in the company at a valuation of $8.5 billion but last week lowered it to $7.5 billion, according to one of the private market sources.

The lack of interest in WeWork stock is a further indication of how confidence in WeWork has cratered in the space of a few weeks, the private market sources said.

WeWork could itself acknowledge that its valuation has fallen below $10 billion based on any agreement it makes for a new financing lifeline, according to two people familiar with the matter. SoftBank is in talks for a multi-billion dollar rescue deal that could lead to it taking control of WeWork, while JPMorgan has been in negotiations over a competing debt package, these people said.

WeWork’s IPO failure, as well as the sinking stock prices post-IPO of some major companies, such as Uber Technologies Inc and Lyft Inc, have had a chilling impact on the private over-the-counter market in shares. Investors are particularly wary of any companies that have high valuations and no immediate route to profitability.

“There’s just a greater level of scrutiny overall in terms of transactions in the private market,” Leung said.

(Reporting by Joshua Franklin in New York and Anirban Sen in Bengaluru; Editing by Martin Howell and Lisa Shumaker)

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