For­mer MiMedx CEO and COO are con­vict­ed on fraud, con­spir­a­cy charges

The MiMedx saga — which has in­clud­ed a months-long in­ves­ti­ga­tion, FBI in­volve­ment and al­le­ga­tions that the com­pa­ny fraud­u­lent­ly boost­ed its sales — has re­sult­ed in the con­vic­tion of two for­mer ex­ec­u­tives. But it isn’t quite over yet.

Park­er “Pe­te” Pe­tit

For­mer CEO Park­er “Pe­te” Pe­tit and for­mer COO William Tay­lor have been con­vict­ed on a se­cu­ri­ties fraud count and a con­spir­a­cy count, re­spec­tive­ly, in the South­ern Dis­trict Court of New York. The Man­hat­tan US at­tor­ney’s of­fice ac­cused the men of false­ly re­port­ing $9.5 mil­lion of rev­enue in 2015 to boost the com­pa­ny’s stock and fill their own pig­gy banks, per a Law360 re­port.

But the de­fen­dants have de­nied the ac­cu­sa­tions, and say they plan on ap­peal­ing the ver­dict. Pe­tit was ac­quit­ted on a  con­spir­a­cy count, while Tay­lor was ac­quit­ted on a fraud count.

William “Bill” Tay­lor

“We are pleased that the ju­ry ac­quit­ted Mr. Tay­lor of se­cu­ri­ties fraud. We are of course dis­ap­point­ed in the ver­dict on the con­spir­a­cy count, but Mr. Tay­lor ful­ly in­tends to seek to have the ver­dict over­turned,” Tay­lor’s lawyer William Bur­ck told Law360.

MiMedx $MDXG, which pro­duces sur­gi­cal and tis­sue-graft prod­ucts for vet­er­ans and mil­i­tary hos­pi­tals, ran in­to trou­ble back in Feb­ru­ary of 2018, when the FBI showed up at the door of Marc Co­hodes. The vo­cal short sell­er had in­sult­ed the com­pa­ny and Pe­tit in hun­dreds of tweets. Af­ter FBI agents or­dered Co­hodes to stop, his lawyer went to the US De­part­ment of Jus­tice with a com­plaint.

The DOJ seemed to be al­ready in­ves­ti­gat­ing MiMedx’s sales and dis­tri­b­u­tion prac­tices. The com­pa­ny faced law­suits brought by ex-em­ploy­ees who ac­cused it of fraud­u­lent­ly boost­ing sales. And it spent sev­er­al years chal­leng­ing the FDA on whether its prod­ucts met reg­u­la­to­ry stan­dards.

MiMedx said it was con­duct­ing an in­ter­nal in­ves­ti­ga­tion in Feb­ru­ary of 2018, and that it would re­state its fi­nan­cial state­ments go­ing back six years. It part­ed ways with Pe­tit and Tay­lor and slashed 24% of its work­force to start a “new chap­ter.” By No­vem­ber, it delist­ed from Nas­daq.

The in­ter­nal in­ves­ti­ga­tion, con­duct­ed by King & Spald­ing with KP­MG as an au­di­tor, turned up a slew of ac­cu­sa­tions, in­clud­ing that MiMedx made ma­te­r­i­al mis­state­ments and omis­sions about its deals, that Pe­tit lied un­der oath when dis­cussing its largest dis­trib­u­tor, and that the com­pa­ny’s ac­tions were “de­signed to ma­nip­u­late the tim­ing and recog­ni­tion of rev­enue.”

The com­pa­ny’s shares, which once trad­ed at a high of $16.75, closed at $6.79 apiece on Thurs­day.

What comes next for the for­mer ex­ecs? Pe­tit is sched­uled for sen­tenc­ing on Feb 23, and Tay­lor is due back the fol­low­ing day. Pe­tit could be look­ing at up to 20 years for the se­cu­ri­ties fraud count, while Tay­lor’s con­spir­a­cy count could land him up to 5 years.

A cor­rec­tion has been made to re­flect that Pe­tit was ac­quit­ted on a con­spir­a­cy count, not a se­cu­ri­ties fraud count.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Anthony Fauci (AP Images)

West Vir­ginia man faces prison time for threat­en­ing emails to Fau­ci, oth­er health of­fi­cials

NIAID director Anthony Fauci gained hero status amid the pandemic, earning Americans’ trust and even Time magazine’s Guardian of the Year title. But he and other federal health officials have also faced intense threats, according to charges brought by the US Department of Justice.

A West Virginia man is facing up to 10 years in prison after threatening Fauci, former NIH director Francis Collins, and HHS assistant secretary for health Rachel Levine via email, the DOJ said on Monday. Thomas Patrick Connally, Jr., pleaded guilty on Monday to using an anonymous email address to threaten the officials for performing their official duties, including discussing Covid-19 testing and prevention.

Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Stéphane Bancel, Moderna CEO (Charles Krupa/AP Images)

Mod­er­na chief Ban­cel to do­nate about $355M worth of ear­ly stock to char­i­ty

Four days ago, Moderna CEO Stéphane Bancel was made a Chevalier — basically knighted — in his home country of France. And now the billionaire CEO said he will exercise and donate about  $355 million in stock options.

Bancel announced early Tuesday via a blog post that he and his wife Brenda will be donating the after-tax proceeds of his original stock options to charity — the stock options Bancel was granted back in 2013 after he became CEO, two years after he first joined the mRNA specialist outfit.

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Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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(Credit: Shutterstock)

Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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David Sinclair, Genocea Biosciences co-founder (Alpha Wave Global)

Geno­cea reach­es end of road, delist­ing from Nas­daq and let­ting go of re­main­ing staff

A pivot into neoantigen immunotherapies was not enough to save Genocea Biosciences after all.

The 16-year-old biotech said it would be closing down and laying off all remaining employees “except those deemed necessary to complete an orderly wind down” of operations. It has also delivered a formal notice to Nasdaq, notifying the stock exchange of its intent to delist voluntarily.

The move comes a month after Genocea laid off 75% of its workforce and revealed it’s looking for strategic alternatives, such as a sale, merger or reverse merger. At the end of 2021, it had 74 employees.

Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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