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Evofem Biosciences Inc (OTCMKTS: EVFM) Steady Rise Northbound as Co Uplists to OTCQB Venture & Phexxi Approved in Nigeria While Sales Pick Up Rapidly

Evofem Biosciences Inc (OTCMKTS: EVFM) has been on the move northbound in recent trading since reversing off $0.071 new 52-week lows. The Company was delisted…

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Evofem Biosciences Inc (OTCMKTS: EVFM) has been on the move northbound in recent trading since reversing off $0.071 new 52-week lows. The Company was delisted by the Nasdaq in August for failing to meet the minimum bid requirements and at $0.26 is trading at a fraction of the $8 it commanded in March or the $100 per share EVFM was trading at just 2 years go. Everyone knows how explosive ex Nasdaq can be once on the OTC and EVFM has big potential; the Company recently launched its first FDA-approved product, Phexxi® a hormone-free, on-demand prescription contraceptive vaginal gel.  

Sales of Phexxi have been picking up rapidly with EVFM reporting $10.25 million in revenues in the first 6 months of 2022. Revenues are expected to continue to grow at a brisk rate, recently another highly respected national-level payer began covering Phexxi. The Phexxi claim approval rate reached a new high for 2022 at more than 72% for the month of July. EVFM has been busy this month; they uplisted to the OTCQB Venture Market from the OTC Pink Open Market. Phexxi has also been approved by the Nigerian Regulatory Agency NAFDAC (National Agency for Food and Drug Administration and Control). This marks the Company’s first approval outside the United States. Regulatory dossiers have also been submitted in Ghana, Ethiopia and Mexico. The product will be potentially marketed under the brand name Femidence.    

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Evofem Biosciences Inc (OTCMKTS: EVFM) is developing and commercializing innovative products to address unmet needs in women’s sexual and reproductive health, including hormone-free, woman-controlled contraception and protection from chlamydia and gonorrhea. The Company’s first FDA-approved product, Phexxi® (lactic acid, citric acid and potassium bitartrate), is a hormone-free, on-demand prescription contraceptive vaginal gel. It comes in a box of 12 pre-filled applicators and is applied 0-60 minutes before each act of sex. Last week the Company completed Phase 3 EVOGUARD clinical trial evaluating EVO100 for the prevention of chlamydia and gonorrhea infection in women did not achieve its endpoints. 

Phexxi was approved by the FDA on May 22, 2020 and is the first and only FDA-approved, hormone-free, woman-controlled, on-demand prescription contraceptive gel for women. Evofem commercially launched Phexxi in September 2020 in the United States. The Company intends to commercialize Phexxi in all other global markets through partnerships or licensing agreements. 

EVO200 vaginal gel (EVO200), Evofem’s investigational candidate for the reduction of recurrent bacterial vaginosis (BV), uses the same proprietary vaginal pH modulator platform as Phexxi. EVO200 has been designated a QIDP by the FDA for this indication. In a Phase 1 dose-finding trial for this indication, the highest dose formulation of the study drug demonstrated reduced vaginal pH for up to seven days following a single administration. We may decide to pursue further development of EVO200 in the future. 

Phexxi, EVO200, and other product candidates in development share similar non-hormonal, acid-buffering, bioadhesive properties. However, they are designed differently to target viral and bacterial pathogens while playing an integral role to the survival of healthy bacteria in the vagina, enabling women to achieve better sexual and reproductive health. 

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EVFM

EVFM has been busy this month; they uplisted to the OTCQB Venture Market from the OTC Pink Open Market. The women’s health focused biotech company developed and commercializes Phexxi® (lactic acid, citric acid, potassium bitartrate), the first and only FDA-approved hormone-free, contraceptive vaginal gel. Phexxi net sales have increased for three consecutive quarters; the Company expects that third quarter results, due in mid-November, will continue this trend. Net product sales of the hormone-free contraceptive had already surpassed 2021 levels in the first half of 2022.    

Evofem is on track to report top-line data in mid-October 2022 from its registrational Phase 3 clinical trial evaluating Phexxi for the prevention of chlamydia and gonorrhea in women. Positive study outcomes would enable regulatory submissions and potential approval for these potential new indications in 2023.  If approved by the FDA, Phexxi will be the first woman-controlled prescription prophylactic against chlamydia and gonorrhea, which are a significant and growing public health concern. Preliminary CDC data for 2021 show that infections with chlamydia and gonorrhea continued to increase during the second year of the COVID-19 pandemic, with no signs of slowing. 

Phexxi has also been approved by the Nigerian Regulatory Agency NAFDAC (National Agency for Food and Drug Administration and Control). This marks the Company’s first approval outside the United States. Regulatory dossiers have also been submitted in Ghana, Ethiopia and Mexico. The product will be potentially marketed under the brand name Femidence.    

In October 2020, Adjuvant Capital made a $25 million strategic investment to expand global market access for Phexxi® (lactic acid, citric acid, potassium bitartrate) vaginal contraceptive gel and to support EVOGUARD, Evofem’s registrational Phase 3 clinical trial evaluating Phexxi for the prevention of chlamydia and gonorrhea in women. Evofem is on track to report top-line data from this landmark trial in mid-October 2022. Positive study outcomes would enable regulatory submissions and potential U.S. approval for prevention of these sexually transmitted infections in 2023. As previously reported, Evofem has experienced strong growth in net sales of Phexxi® (lactic acid, citric acid and potassium bitartrate), as well as market access expansion, as payers and pharmacy benefit managers (PBMs) continue to add Phexxi to their formularies, allowing women to fill their prescriptions immediately. 

 

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Currently trading at a $14 million market valuation EVFM OS is 25,877,050 shares with authorized at 500 million. With $20 million in cash in the treasury EVFM was recently able to restructure its debt, providing forbearance from its debtholders related to all existing events of default. EVFM is an exciting situation in small caps; the Company was delisted by the Nasdaq in August for failing to meet the minimum bid requirements and at $0.26 is trading at a fraction of the $8 it commanded in March or the $100 per share EVFM was trading at just 2 years go. Everyone knows how explosive ex Nasdaq can be once on the OTC and EVFM has big potential; the Company recently launched its first FDA-approved product, Phexxi® a hormone-free, on-demand prescription contraceptive vaginal gel. Sales of Phexxi hormone-free, on-demand prescription contraceptive vaginal gel sales have been picking up rapidly with EVFM reporting $10.25 million in revenues in the first 6 months of 2022. EVFM has a lot of potential from current levels; some of the biggest runners in small history over the past 10 years have been ex big bord biotech’s, EVFM should be at the top of penny stock speculators watch lists here. We will be updating on EVFM when more details emerge so make sure you are subscribed to Microcapdaily.

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Disclosure: we hold no position in EVFM either long or short and we have not been compensated for this article.

The post Evofem Biosciences Inc (OTCMKTS: EVFM) Steady Rise Northbound as Co Uplists to OTCQB Venture & Phexxi Approved in Nigeria While Sales Pick Up Rapidly first appeared on Micro Cap Daily.

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International

Rent Control Is A Disaster – Don’t Let It Spread Across The Nation

Rent Control Is A Disaster – Don’t Let It Spread Across The Nation

Authored by Betsy McCaughey via The Epoch Times,

America’s renters -…

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Rent Control Is A Disaster - Don't Let It Spread Across The Nation

Authored by Betsy McCaughey via The Epoch Times,

America’s renters - more than one-third of the nation’s households - are in for trouble.

Left-wing politicians are demanding rent regulation from coast to coast. Wherever it is adopted, the result will be a disastrous reduction in the rental housing supply, leaving renters desperate for places to live.

New York is the poster child for the failures of rent regulation. The U.S. Supreme Court is currently mulling a challenge to the constitutionality of the city’s rent regime.

Whatever the justices decide, the public needs to consider less destructive, more targeted ways to help low-income people pay for housing. The court of public opinion needs to consider these facts.

Fact No. 1: Rent regulation isn’t targeted to the poor.

In New York, there’s no means test. What you need is luck or connections. The mean income of a rent-stabilized apartment dweller is $47,000, but census data show that tens of thousands of them earn more than $150,000 per year. Some occupants use what they’re saving on rent to pay for a weekend place in the Hamptons or New England.

The pols don’t object—a sure sign they’re calling for rent regulation to help themselves politically, not the poor.

In New York, 44 percent of rental apartments are regulated by the Rent Guidelines Board (RGB), established in 1969, which sets the maximum amount by which landlords are allowed to raise the rent. Those limits apply to all buildings of six or more units built before 1974.

In 2022, the RGB set the maximum rent hike at 3.25 percent on one-year leases and this year at 3 percent. Never mind that last year, fuel costs to heat the buildings soared by 19 percent and overall inflation hit 8.3 percent.

The decisions are political, not economic. Many Democratic politicians vilify building owners as “greedy landlords” and depict themselves as the champions of the downtrodden. It’s a scam.

Fact No. 2: Winners and losers.

The winners are the lucky few with rent-regulated apartments and the pols who count on an army of tenant activists to turn out at the polls. The losers are the 56 percent of renters who don’t score a regulated apartment and have to scour neighborhoods for an unregulated place that they can afford. They’re paying more.

Why? Because regulation causes some landlords to walk away, reducing the overall supply of apartments. The laws of supply and demand mean rents go up. New Yorkers in unregulated apartments are paying the highest rents in the United States for a one-bedroom apartment. They're the real victims, and they should be furious.

Yet the left-wing press pretends that rent control offers only benefits. The New Republic warns that the Supreme Court challenge threatens “laws that have benefitted the city’s tenants for generations.” Sorry, untrue—only some tenants, and not always the neediest.

It’s economic madness. The saner way to help those who need assistance paying rent is with a voucher. We offer the needy SNAP debit cards to help them pay for groceries. No one slaps price controls on grocery stores or designates certain stores as “regulated,” forcing them to sell at below cost.

Yet New York forces certain landlords to pay what should be a public cost shared by all, an argument made to the court.

Fact No. 3: The Marxist fantasy that rent regulation will help the poor is spreading across the United States and Europe as well.

Maine and Minnesota have enacted laws allowing municipalities to impose rent regulations. In November 2024, California voters will be asked to approve a proposition allowing local governments to add additional restrictions to the state’s existing rent caps.

The laws of supply and demand are international. Berlin froze rents in 2019, and the rental supply plummeted, according to the Ifo Institute, a think tank.

Yet London Mayor Sadiq Khan is calling for freezing rents for two years. London provides housing vouchers to the poor—a smarter approach—but when the city froze the voucher amounts during the COVID-19 pandemic, fewer apartments were available in the price range. The answer is to raise the voucher amount. Freezing rents will only make the shortage worse.

Ignore the demagogues. The evidence is in: Rent regulation is a political scam. There are better ways to help Americans afford a place to live.

Tyler Durden Sat, 10/14/2023 - 16:20

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Government

‘No Regrets’: Former CIA Director Repeats Debunked Russian Disinfo Claims About Hunter’s Laptop

‘No Regrets’: Former CIA Director Repeats Debunked Russian Disinfo Claims About Hunter’s Laptop

In an interview last night with Fox’s Bret…

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'No Regrets': Former CIA Director Repeats Debunked Russian Disinfo Claims About Hunter's Laptop

In an interview last night with Fox's Bret Baier, former CIA Director Leon Panetta humiliated himself as he defended the letter that he and 50 other so-called 'intelligence officials' signed suggesting that the Hunter Biden laptop was Russian disinformation.

Even more unsettling were his comments that he believes it could still be Russian disinformation.

“That letter was used in the debate, I haven’t asked you this but do you have regrets about that now looking back, knowing what you know now?” Baier asked.

Panetta explained that he was “extremely concerned about Russian interference” in the run up to the 2020 Presidential Election between then-former-Vice President Joe Biden and then-President Donald Trump.

He claimed that intelligence agencies discovered that “Russia had continued to push disinformation across the board.”

He said that he wanted to “alert the public” about the “disinformation efforts” to influence the election.

“And frankly, I haven’t seen any evidence from any intelligence agency that that was not the case,” Panetta said.

“You don’t think that it was real?” Baier asked.

“I think that disinformation is involved here. I think Russian disinformation is part of what we’re seeing everywhere,” Panetta responded.

“I don’t trust the Russians, and that’s exactly why I was concerned that the public not trust the Russians either.”

And finally, Baier asked if Panetta had any regrets over how he handled the story.

“No, I don’t have any regrets about not trusting the Russians,” Panetta said.

As Jonathan Turley pointed out,Panetta simply refused to acknowledge:

(1) American intelligence quickly debunked the claim and said that there was no evidence of Russian disinformation behind the laptop,

(2) the emails contained in the laptop were quickly authenticated by the other parties,

(3) the FBI authenticated the laptop,

(4) Hunter Biden has since sued over the use of his laptop, and

(5) the media has independently authenticated the laptop.

This was the man in charge of our CIA.

As a reminder, it has also been shown that the Biden campaign and associates coordinated the letter.

Watch the lying liar lie below...

We give the last word back to Turley who summarized the former spook's self-immolation perfectly: "Panetta has become the personification of the economic theory of path dependence. No matter how much countervailing evidence is presented to Panetta, he still refuses to accept the authenticity of the laptop."

However, in order to admit to these facts, Panetta would have had to admit that he was a willing or unwitting dupe of the campaign. It is easier to simply continue to claim that this could all be the invention of the Russians.

Yet, as Turley exclaims, Panetta is still sought for his advice on other intelligence matters as he continues to repeat disproven claims because the truth is simply too costly on a personal level to acknowledge.

What do we call false claims that are repeated despite being repeatedly debunked and disproven? Oh, yea, disinformation.

Tyler Durden Sat, 10/14/2023 - 14:35

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Bibi & Khamenei Trade Social Media Threats As IDF Readies For Air, Ground, & Naval Offensive Against Gaza “Very Soon”

Bibi & Khamenei Trade Social Media Threats As IDF Readies For Air, Ground, & Naval Offensive Against Gaza "Very Soon"

Update (1330ET):…

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Bibi & Khamenei Trade Social Media Threats As IDF Readies For Air, Ground, & Naval Offensive Against Gaza "Very Soon"

Update (1330ET): The Israeli military has announced it is prepared for a coordinated air, ground and naval offensive in the Gaza Strip "very soon," according to reports from AP.

In a nationally broadcast address Saturday night, Rear Adm. Daniel Hagari issued a new appeal to residents to move to the southern Gaza Strip.

“We are going to broadly attack Gaza City very soon,” he said.

He accused Hamas of trying to use civilians as human shields.

Meanwhile, the social media rhetoric between leaders has gone to '11'...

Iran's Supreme Leader Khamenei expects a "complete victory"...

Calling on all Muslims to join the fight...

Israeli PM Netanyahu made his views very clear:

Live feeds below on Gaza: 

*  *  *

Israeli media is reporting a "greenlight" has been given for the expected major Israeli offensive on the Gaza Strip as massive convoys of Palestinian civilians have been observed fleeing to the southern part of the densely populated strip. So far there has been limited ground incursions by the army into the strip, targeting Hamas operatives and reportedly to gain intelligence on the whereabouts of hostages. 

The United Nations has issued a report saying at least 423,000 Palestinians have already been internally displaced within Gaza and this massive figure is expected to ratchet further. Likely it has surpassed a half-million as of Saturday, following the Israeli-issued evacuation order, which included dropping thousands of leaflets and warnings over Gaza City. 

Via The Guardian

The UN said it "considers it impossible for such a movement to take place without devastating humanitarian consequences." Middle East Eye and other regional sources have said over 700 Palestinian children were killed in one week of fighting. As of Friday Israel authorities tallied that over 1,300 Israelis were killed by the Hamas terror attacks on the southern settlements and the music festival, and rocket fire, with at least 3,200 wounded. 27 among the dead were Americans.

Middle East Eye on Saturday reports the following of the mounting Palestinian death toll in both Gaza and the West bank as follows:

Israel has killed at least 2,215 people in Gaza over the past week, according to the Palestinian health ministry. Of those killed, 724 are children and 458 are women. Some 8,714 people have been wounded in the besieged enclave in that time, it added. 

Meanwhile, Israeli forces have killed 54 people and wounded 1,100 others in the occupied West Bank.

According to a review of the last hours of developments, the population is about to run out of water as the remaining supply dwindles after Israel cut off external supply sources

  • UN agency for Palestinian refugees says its shelters in Gaza “are not safe anymore” as it warns water running our for besieged enclave’s residents.
  • More than 320 Palestinians have been killed in the past 24 hours, including many women and children killed in Israeli air raids on convoys fleeing Gaza City, according to health officials.
  • The rising toll comes as Israel continues bombing Gaza a day after telling 1.1 million residents to head south ahead of a looming ground offensive following Hamas’s attack inside Israel last week.
  • At least 2,215 Palestinians have been killed and 8,714 wounded in Israeli air attacks on Gaza. The number of people killed in Israel has reached 1,300, with more than 3,400 wounded.
  • In the occupied West Bank, the number of Palestinians killed by Israeli fire in the past week has topped 50. More than 1,000 have been wounded and hundreds arrested.

The fate of the estimated 100 to 200 hostages in Hamas captivity still remains largely unknown, but Hamas in statements which have been underreported in Western press has claimed that over two dozen of the hostages have been killed by the IDF's ongoing aerial bombardment of the Gaza Strip

Hamas' Izz al-Din al-Qassam Brigades said nine more captives were killed in indiscriminate Israeli shelling in the last 24 hours, including a number of foreigners

Qassam has previously announced the death of 17 captives in Israeli air stikes in Gaza over the past week. 

Sky News and others are also reporting, based on Israeli sources, that bodies of hostages have been recovered after some of the initial IDF infantry cross-border raids which began Friday into Saturday:

Raids carried out on the Gaza Strip by Israeli forces discovered human remains of those who had been missing since Hamas's attack last weekend, local media is reporting.

According to Haaretz, armed forces entered an enclave where it is thought up to 200 people were being held hostage by Hamas, and retrieved the bodies of several people.

Items belonging to the missing people were also discovered. 

The US said Friday it chartered its first successful evacuation flight, with talk of more to come.

TOI: A military official at the forensic center at the Military Rabbinate's headquarters in Ramle stands in front of the remains of the victims of Hamas's October 7 shock onslaught in Israel, October 13, 2023. Flash90

There are Americans (many of them likely dual nationals) among the population of Gaza, which Washington says it is trying to facilitate safe exit for as Israeli airstrikes continue. Dangerously, the lone Raffah border crossing into Egypt has at this point been bombed several times. 

But regional media is reporting there's been a diplomatic breakthrough on this front, as Israel, Egypt, and the United States have forged an agreement to let foreigners residing in Gaza pass through the Rafah border crossing into Egypt.

Scene from the frontlines as the IDF build-up outside Gaza continues:

Huge civilian convoys have been witnessed fleeing to the southern half of Gaza, creating bottlenecks...

The Times of Israel cites a senior Egyptian official as follows:

The official says Israel has agreed to refrain from striking areas the foreigners would pass through on their way out of the besieged Palestinian territory. He adds that Qatar was involved in the negotiations and the participants received approval from the Palestinian terror groups, Hamas and Islamic Jihad.

The agreement  does not deal with hostages being held by Hamas.

A second official at the Egyptian side of the Rafah crossing point says they received “instructions” to reopen it on Saturday afternoon for foreigners coming from Gaza.

But Egypt is by and large not letting Gazans exit, even erecting bigger concrete barriers of extra border protection, amid what's setting up to be a catastrophic humanitarian crisis as the Israeli pressure ratchets.

The IDF says it is about to attack the northern half of the Gaza Strip with "great force" - while the US and other countries are urging for caution regarding Palestinian civilians. Below is rare footage of an elite Israeli rescue squad in action (intentionally blurred by IDF sources):

Washington has still all the while said it "stands with Israel" - and has not tried to actually halt the unrelenting IDF bombardment of civilian areas.

Meanwhile, things continue ratcheting in south Lebanon, with reports of new strikes being exchanged between Israel and Hezbollah, and other pro-Palestinian factions.

Tyler Durden Sat, 10/14/2023 - 13:40

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