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Local
Forest Ridge road project begins Monday

The already-busy Forest Ridge Boulevard is about to get even more congested.

Starting Monday, work will begin on resurfacing a roughly 1.5-mile stretch from County Road 486 to West Lake Beverly Drive.

Detours will be in place. The project is expected to take three to four weeks.

The affected area is home to Forest Ridge Elementary, Forest Ridge Senior Residences and Central Ridge Library so traffic is pretty thick during certain times of the day.

Library Director Eric Head said patrons should not be affected too much by the roadwork.

“We’re in good shape,” he said. “We have two entrances – one off Forest Ridge and one off Roosevelt so (patrons) can use either one. “Access to the library should be impacted minimally.”

This resurfacing project is being funded jointly by Citrus County and the Florida Department of Transportation’s (FDOT) Small County Outreach Program (SCOP) resurfacing project.

The FDOT will fund 75 percent and the rest comes from gas tax revenue.

The SCOP program assists small county governments in repairing or rehabilitating county bridges, paving unpaved roads, addressing road-related drainage improvements, resurfacing or reconstructing county roads, or constructing capacity and safety improvements.

Citrus County meets the eligibility requirements of a population threshold of 170,000 people or less.

The SCOP resurfacing projects are programmed about five years in advance.

For more information about this road project, call the county’s engineering division at 352-527-5446.


Local
Gallery celebrates local artists

When you’re an artist, when you’re in the middle of a project, when you’re inspired and in the moment and suddenly realize you need a certain color of paint or a certain brush, you don’t want to have to drive an hour or more to the nearest art supplies store.

mattbeck / Matthew Beck / Chronicle photo editor 

Crystal Adams sells items including “hippy garb” from her Hernando art studio.

“It takes you out of the mood,” said Crystal Adams, artist and owner of A Cracker Canvas.

The art supplies store and gallery at 2211 E. Norvell Bryant Highway (County Road 486) in Hernando opened in February 2022.

She named it “Cracker” because of her Florida heritage.

“To me, ‘cracker’ is about knowing your home, knowing your history.” Adams said. “The cracker way is running barefoot, going fishing in the rivers and the streams. There’s a lot of beauty to Florida.

“This shop is something I wanted to do for the last 20 years,” Adams said.

She said wanted a place where local artists didn’t have to travel for supplies, but also where they could display their creations and sell them on consignment from her store.

“After hanging my acrylic and watercolor paintings along with my wool felted tapestries, I realized there was space to allow local artists a chance to display their pieces as well, at a reasonable commission.

“Having been on that side of the aisle between traveling to shows to paying excruciating commissions to other shops, I wanted to help struggling talent, as there is plenty of it here in Citrus, giving them a voice that may possibly go unheard,” she said, adding, “I like the variety of the art that comes in ... it makes the store more interesting.”

Visitors to her website, www.crackercanvas.com, can take a visual tour of her store and view the hand-hammered, copper yard art, the locally crafted pottery, metal and wood sculptures, paintings and drawings, jewelry and Adams’ own tapestries, “hippie chick” apparel and more.

And, of course, art supplies, from canvases, brushes and palette knives to paints, inks, markers, charcoals, pencils, etc.

The outside of the store, the former Xtreme Party Store, is nondescript, but the inside feels airy and well-thought out and reminiscent of an art museum gift shop.

mattbeck / Matthew Beck / Chronicle photo editor 

Sculpture, yard art and other mediums are on display at Cracker Canvas in Hernando.

“I wanted a shop that’s not overwhelming, where you can enjoy coming to,” she said. “When there’s too much, you don’t even know what you’re looking at.”

Prior to going into this business, Adams, 60, worked in construction. She and her husband built screened rooms and pool enclosures.

“It was time to stop doing that, but not time to just stop,” she said.

They moved to Citrus County from Lake County in July 2021.

“We wanted a change of pace,” she said. “Lake County was getting crowded and crazy and costly. It’s so mellow here.”

Adams, a third-generation Floridian, grew up in Seminole and Orange counties, the only girl in her family among five brothers.

“Art was my escape – that was one thing they weren’t interested in,” she said.

As a teenager and then as a young adult, she found jobs with printing companies and learned graphic art.

“I worked for some big printers in Orlando,” she said. “This was before computers. I did old-style typesetting and layouts by hand ... I’d use clip art or draw my own (images).”

She learned wool felting, which is the art of connecting or blending raw wool together to make a fabric, while she was taking a knitting class.

mattbeck / Matthew Beck / Chronicle photo editor 

Local artists’ work hangs on the walls of the Cracker Canvas in Hernando.

“It’s the oldest way of making fabric for clothing,” she said.

She has several of her finished tapestries on display and for sale in her shop.

“From the time I first opened, I wanted this to be a place for local artists, especially young artists,” she said. “I started having little art festivals in the parking lot, and so far I’ve had pretty good turnouts – and I don’t charge them anything. I just want them to have the exposure and display (and sell) their art.

“One young (teen) artist has even picked up some commission jobs,” she said.

The next art festival is from 4-9 p.m. Saturday, Sept. 17, at A Cracker Canvas, 2211 E. Norvell Bryant Highway (County Road 486) in Hernando.

To reserve a spot, call Crystal Adams at 352-212-4011.

Email: crackercanvas@gmail.com.

Facebook: https://tinyurl.com/yubuwnp6

Store hours: 10 a.m. to 5 p.m. Wednesday through Friday and 10 a.m. to 1 p.m. on Saturday.


Local
Colleen Scott resigns as county budget director

Colleen Scott has submitted her resignation as the county’s director of management and budget, effective Sept. 27.

That date coincides with the final 2022-23 budget hearing.

Scott did not list her reason for leaving in her resignation letter to County Administrator Randy Oliver. She was effusive in her praise for Oliver, who will soon retire.

“It has been such a pleasure to work for you and the citizens of Citrus County,” Scott wrote.

She praised Oliver for being “a great mentor to senior staff.”

Oliver reciprocated those sentiments in a letter to county commissioners.

“Colleen is the consummate professional and the best OMB director that I have had the pleasure to work (with), County Administrator Randy Oliver said. “She has moved the department forward and will definitely be missed.”

The county will advertise the position.

County Commission Chairman Ron Kitchen Jr. said that bond between Scott and Oliver was likely the reason she is resigning.

“I expected her to leave about the same time Randy does,” Kitchen said.

And he expects more staff departures as Oliver’s time with the county grows short.

After more than seven years on the job, Oliver in February submitted his resignation earlier this year and told the board he would stay no later than Nov. 29 for the county to find a replacement.

Kitchen Jr.

“The staff liked Randy and admired him,” Kitchen said.

Kitchen said the current budget “is pretty much set” so there shouldn’t be any problems. And even if there are, Oliver will still be around until November during the transition, he said.

“(Scott) built up a good staff so I think the people there are capable of running things until someone comes on board,” he said.

Scott praised her co-workers and staff in her letter.

“These past few years we have accomplished so much: one of the top three counties to disburse CARES funds in record time, working through COVID without impacting operations, revising administrative regulations to align with Governmental Accounting Standards Board (GASB) and, most important of all, to continue to achieve the Distinguished Budget Presentation Award, reflecting a budget of the highest quality and transparency.”


AP
FDA panel backs much-debated ALS drug in rare, 2nd review
A panel of federal health advisers has voted to recommend approval for an experimental drug to treat Lou Gehrig’s disease

WASHINGTON (AP) — A panel of federal health advisers voted Wednesday to recommend approval for an experimental drug to treat Lou Gehrig’s disease, a remarkable turnaround for the much-debated medication that was previously rejected by the same group earlier this year.

The Food and Drug Administration advisers voted 7-2 that data from Amylyx Pharma warranted approval, despite hours of debate about the strength and reliability of the company’s lone study. The FDA is not required to follow the group's advice, but its positive recommendation suggests an approval is likely later this month.

The FDA has approved only two therapies for the disease, amyotrophic lateral sclerosis, or ALS, which destroys nerve cells needed for basic functions like walking, talking and swallowing.

ALS patients and their families have rallied behind Amylyx’s drug, launching an aggressive lobbying campaign and enlisting members of Congress to push the FDA to grant approval.

Despite a negative review published by FDA’s internal scientists ahead of the meeting, a majority of the outside panelists said Amylyx had presented enough evidence to suggest the drug is helping patients live longer. The same group of neurology experts narrowly voted against the drug in March, due to concerns about missing data and other issues in the company’s study.

“To deprive ALS patients of a drug that might work, it’s probably not something I would feel terribly comfortable with,” said Dr. Liana Apostolova of Indiana University’s School of Medicine, who voted for approval. “At the previous meeting it wasn’t that clear and it’s still questionable.”

Amylyx also appeared to benefit from an unusual exchange in which a company executive — at the FDA’s request — committed to pull the drug from the market if its benefits aren’t confirmed by a large, ongoing study.

“I’m somewhat assured that if an approval is issued it can be withdrawn in the future,” Apostolova noted.

Wednesday’s vote concluded a rare second meeting to review several new statistical analyses submitted by Amylyx in support of the treatment’s benefit in slowing disease and extending life.

The ALS drug review is being closely watched as an indicator of FDA’s flexibility in reviewing experimental medications for the terminally ill and its ability to withstand outside pressure.

Dr. Billy Dunn, FDA’s neurology review chief, opened the meeting by detailing the “concerns and limitations” with Amylyx’s data, while emphasizing the need for new treatment options.

“We are highly sensitive to the urgent need for the development of new treatments for ALS,” Dunn said.

Dunn also noted that a larger Amylyx study being conducted in the U.S. and Europe could provide “more definitive results” by 2024.

In a highly unusual move, Dunn suggested the agency might be more willing to approve the drug if Amylyx would commit to withdrawing its medication if the ongoing 600-patient trial fails to show a benefit. He then called on the company’s co-founders to publicly commit to that step, and Amylyx co-CEO Justin Klee said the company would voluntarily withdraw its drug in that scenario.

The FDA has the power to force companies to pull drugs from the market, though it’s generally faster if drugmakers voluntarily take that step. In cases where companies resist removal the regulatory process can drag on for years.

“I think the FDA — with all due respect — significantly understates the complexity and likelihood of their pulling the product from the market,” said Dr. Caleb Alexander of Johns Hopkins University, one of the two panelists who voted against the drug.

Amylyx conducted one small, mid-stage trial of its drug that showed some benefit in slowing the disease, but it was plagued by missing data and other problems, according to FDA reviewers.

“The final result — for a single study — is borderline and not very statistically persuasive,” FDA statistician Tristan Massie told panelists.

The Cambridge, Massachusetts, company says follow-up data gathered after the study concluded showed the drug extended life. Patients who continued taking the drug survived about 10 months longer than patients who never took the drug, according to a new company analysis.

Panelists favoring the drug cited that data, along with the drug’s mild side effects, to suggest there would be little downside for patients even if it doesn’t ultimately slow ALS.

“The drug is not harmful — it seems like it has a benefit — there’s no safety signal here,” said Dean Follmann, a biostatistician with the National Institutes of Health.

Earlier Wednesday, more than 20 ALS researchers, patients and family members told the advisers they supported approval. The agency has also received more than 1,200 written comments, largely from ALS patient advocates.

“I’m asking you to approve it because I know it works. It’s extending my life and I want that for others,” said Greg Canter, who was diagnosed with ALS in 2018 and participated in Amylyx's study. He credits the drug with improving his lung capacity and slowing his functional decline.

Amylyx’s medication comes as a powder that combines two older drugs: one prescription medication for liver disorders and a dietary supplement used in traditional Chinese medicine.

Hanging over the review is FDA’s controversial approval of the Alzheimer’s drug Aduhelm last year, which was reviewed by the same agency scientists and outside advisers.

In that case, the FDA disregarded the overwhelmingly negative vote by its outside advisers, three of whom resigned over the decision. The agency's approval — which followed irregular meetings with drugmaker Biogen — is under investigation by Congress and federal inspectors.


Follow Matthew Perrone on Twitter: @AP_FDAwriter


The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.


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