Thanks, now we need a Nader interpreter to know what that
Thanks, now we need a Nader interpreter to know what that means!
(1) FDA may have asked for combo RO data since it was also in mono trial, and FDA wanted to compare, but we didn't have any RO data for combo since FDA screwed us and only asked for mono data and combo RO data late in the combo HIV development process. So we went to FDA and filed without any combo HIV RO data, and hoped FDA would accept it later during review. FDA balked at this, i.e. "our RO test was rejected by FDA" means they rejected the idea of submitting RO data later, thus the RTF. This fits best with CYDY not having any combo RO data "if you don't have that [RO] how are you going to be able to .. file the BLA?" and BP saying they didn't do any RO for combo HIV trial. Now CYDY has two companies working to quickly do RO testing, and neither of them is InCellDx. InCellDx bridge probably burned when they filed a patent for LL treatment of Covid.
or
(2) "our RO test was rejected by FDA" means that InCellDx was doing all the RO testing, but FDA rejected it, or that InCellDx or someone else proposed of doing the RO a certain way, but FDA rejected those assays.
I don't think the second interpretation is correct, but the first.
FDA seems to have asked for lots of things after we already had everything we thought they wanted in hand for combo HIV indication. Now we are scrambling to get it. Has nothing to do with InCellDx doing any RO testing for us.
I think the interview that NP gave talking about RO (where BP couldn't provide an assay) was referring to RO for cancer, or maybe even instead NP probably meant an assay showing CCR5 in cancer tissue - I would guess it wasn't ready in time, so CYDY went with someone else? It's possible this all happened after InCellDx tried to file a patent on CYDY's drug for Covid application.
1
CytoDyn Inc (CYDY) Stock Research Links
Scroll down for more posts ▼
Top 10 Most Recent News Articles
The Future of Landscaping Unveiled Get this—PANDAG is set to shake things up at GaLaBau 2026 with their futuristic G1 autonomous mower. This isn't just another piece of lawn equipment; it's practically a tech marvel on wheels, weaving together LiDAR, AI Vision, RTK, and 4G tech to make it the ultimate multitasker for the landscaping industry. We're talking obstacle...
Continue Reading
Waves, Paws, and Passion Who would've thought that dogs catching waves could also catch hearts and wallets? Well, that's exactly what's happening today at Del Mar Dog Beach with the 21st Annual Surf Dog Surf-A-Thon revving up the excitement. It's a sun-soaked day in Rancho Santa Fe, California, right in the thick of things at the longest-running dog surf competition. For...
Continue Reading
GORGIE Targets Taste Buds with Berry Burst Ever feel like you're missing out on that energy drink everyone seems to be raving about? Well, GORGIE's out there making some noise again, and this time it's got a new punchy player in the game: Berry Burst. It's not just another drink; it's shaking things up in the energy aisle with its exclusive launch at Target. Modern style...
Continue Reading
The Game-Changing Results Innovation in pharmaceuticals sometimes feels like a waiting game, but when a fresh breakthrough like this rolls in, it lights up the whole landscape. Risvutatug rezetecan, or Ris-Rez for short, has shown promising potential in the fight against relapsed small-cell lung cancer (SCLC) that has progressed after platinum-based therapy. Survival...
Continue Reading
Rearranging the Consultancy Chessboard Piling onto the game of consultancy realignments, PwC just made a move reminiscent of playing strategy poker. They're tossing together PwC US and PwC India's advisory capabilities for a new joint venture. It’s like pushing two puzzle pieces to make a single colorful picture that stretches from the U.S. all the way to the...
Continue Reading
The High Stakes Reality for UWM Investors If there's one thing that's certain in this jittery world of investing, it's that losses have a way of waking you up. Right now, anyone tied up with UWM Holdings Corporation (NYSE: UWMC) shares needs to keep their wits about them; we're barreling toward an October 13, 2026 deadline for a class action lawsuit. The clock's ticking...
Continue Reading
Dissecting the Nuances of the EVOKE-03/KEYNOTE-D46 Trial Every once in a while, we come across a trial that rattles cages in the research community. Today, it's the EVOKE-03/KEYNOTE-D46 trial, a collision of hope and hard-knock reality. This Phase 3 trial, which sought to explore the potential combo of sacituzumab govitecan (SG) and pembrolizumab on metastatic non-small...
Continue Reading
Regeneron’s Tight Spot: Legal Showdown Well, here we go again—Regeneron Pharmaceuticals (NASDAQ:REGN) is under some serious heat. If you're an investor who faced significant losses with this biotech juggernaut, remember that the clock’s ticking down to the wire. By tomorrow, September 14, 2026, you need to decide if you're going to throw your hat in the ring for...
Continue Reading
Understanding Homeowners Insurance: Beyond the Basics Most folks diving into homeownership for the first time get caught up in the whirlwind of price tags, loans, and knick-knacks for their new place. Meanwhile, the nitty-gritty of homeowners insurance often gets tossed to the side. But take it from a weary watchdog of financial storms—it’s those details in the policy...
Continue Reading
Shifting the Standard: MRI's Rise in SCLC Treatment Here's a twist that baffles the traditionalists—ditch the prophylactic cranial irradiation (PCI) and catch clearer days with MRI surveillance for small-cell lung cancer (SCLC). The latest international phase III MAVERICK trial might just redraw the lines on what's considered standard care in this relentless disease....
Continue Reading
Top 5 Most Recently Viewed Articles
Haivision StreamHub and MoJoPro Revolutionize Mobile Broadcasting Haivision Systems Inc. (TSX: HAI), a leader in real-time video networking, has launched an innovative mobile broadcasting solution. Now available on the AWS Marketplace, the pairing of Haivision StreamHub with the MoJoPro app changes the game for journalists, video professionals, and broadcasters. They can...
Continue Reading
Keurig Dr Pepper's Strategic Acquisition Plans for JDE Peet's In a noteworthy announcement, Keurig Dr Pepper Inc. (NASDAQ: KDP) and JDE Peet's N.V. are making headlines with their plans regarding a public offer. This joint statement serves to inform stakeholders about the progress on KDP's intended recommended public offer for all outstanding shares of JDE Peet's. Basis...
Continue Reading
Join Wreaths Across America This December This December, Wreaths Across America (WAA), a national nonprofit, is gearing up for a meaningful wreath season. With over 20 new loads in need of carrier support, WAA is on the lookout for dedicated carriers and professional drivers who want to take part in its mission to Remember, Honor, and Teach. This initiative is set to...
Continue Reading
iMD Companies and Riize Health Launch New Supplements iMD Companies, Inc. (OTC: ICBU) and its subsidiary, Riize LLC, are making waves in the health sector by introducing three new non-prescription products designed for online and retail distribution. The launch is set for the first quarter of the upcoming year and aims to cater directly to consumer needs in the...
Continue Reading
Activist Investors Surge in 2024 By Svea Herbst-Bayliss A remarkable shift occurred in 2024 as a record number of activist shareholders launched campaigns aimed at global companies. Recent reports highlight that tactics employed by these shareholders have yielded impressive returns, which suggests a continued rise in these activities as we progress into the future. Rising...
Continue Reading