Replies to post #1405 on UniCycive Therapeutics Inc (UNCY)

[timberwolf7]

NOT TRUE with regard to the firings Got a lot of democrat holdovers up there
in the federal agencies still resisting and trying to protect the dems agenda even if
it conflicts with doing whats RIGHT for AMERICA and its citizens.

On July 16th JFK Jr dismissed his two top deputies without cause.


https://www.thelibertybeacon.com/fda-approved-c-19-jab-for-kids-behind-kennedys-back-two-hhs-aides-fired/

The U.S. Food and Drug Administration (FDA) quietly granted full approval to Moderna’s mRNA COVID-19 injection for children while Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. was on vacation—and without his knowledge or consent.
As head of the department overseeing the FDA, Kennedy should have been directly informed of any decision involving pediatric mRNA shots—especially one as politically and medically sensitive as full approval for children as young as six months.

On July 10, Moderna, Inc. announced the FDA approved the supplemental Biologics License Application (sBLA) for Spikevax®, the Company’s COVID shot, in “children 6 months through 11 years of age who are at increased risk for COVID-19 disease.”

The approval was made despite Moderna’s own scientists’ admission that there are “unacceptable toxicity” levels in mRNA vaccines, and that “lipid nanoparticle structural components, production methods, route of administration and proteins produced from complexed mRNAs all present toxicity concerns.”

According to multiple sources, neither Kennedy nor his Deputy Chief of Staff Stefanie Spears were briefed or consulted ahead of the decision, raising alarm over internal operations at one of the nation’s most powerful health agencies.

On July 17, CNN reported that Secretary Kennedy had fired two of his top aides “in an abrupt shakeup of the leadership at the nation’s sprawling health department,” also citing unnamed sources.

“Kennedy’s chief of staff, Heather Flick Melanson, and deputy chief of staff for policy Hannah Anderson left HHS after only a handful of months on the job, following internal clashes that culminated in both of their removals this week,” the report explained.

[Whalatane]

Its the CDER that counts

While it is still early in Dr. Tidmarsh's tenure as CDER director (appointed July 2025), several changes to accelerate drug approval have already been implemented or are being considered by the FDA leadership:

I still expect a Class 2 re submission but a Class 1 is not totally out....maybe 30% chance WAG

Re being having to endure etc .
I look at this as waiting patiently ( hard to do I know ) ) for what may become an excellent buying opportunity . That being when / if the Co announces a small capital raise after getting a Class 2 resubmission notice .
IF the stock ends up on the day of this capital raise ( if it happens ) ...that for me is an excellent buy signal ...reminiscent of my experience with Myocardia ( MYOK ) now bt out.

As you know ...I'm a big believer in OLC seeing a rapid uptake once its in the dialysis clinics ( which has been a problem with Velphoro ) ...and possibly dominating in 2027 as being the only new pho binder to still have 100% Medicare reimbursement. .
If approval is delayed ( not denied ) ...it gives the Co more time to get OLC in front of Nephrologists ...note recent Journal article .....and more time for the clinics to get fully up to speed storing and dispensing the pho meds .

Meanwhile theres action elsewhere ...chk my "boards posted on " if you want to see where I and some others here are active .
Good luck
Kiwi

[Fred Kadiddlehopper]

Agreed in that chaos is a real part of the investor's landscape now. I'm assuming delays are going to be a reality, it's just hard to predict whether any particular company will be directly affected. Companies whose products are near the finish line may benefit as remaining FDA staff try to manage their increasingly impossible caseloads by pushing out the easier decisions more rapidly, while others that require more scrutiny will likely languish for lack attention by overworked and demoralized workers. (There is a similar thing going on at the IRS from what I've heard.)

[Whalatane]

Theres also this https://www.pharmavoice.com/news/fda-drug-reviews-marty-makary-vouchers/751895/ ...related but shows intent
and this
https://www.pharmavoice.com/news/fda-elsa-ai-makary-pharma-drug/749840/
JMO
Kiwi