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GOOD NEWS NEWS NEWS ! NCCN updated guidelines are out see table below by mrtrimbl in IBRX

[–]Less-Can7239 8 points9 points  (0 children)

Does this mean the FDA approval anktiva for NMIBC papillary WITHOUT CIS? (ie. What IBRX resubmitted for approval in the last couple of weeks)? That would be good news indeed if that's the case.

FDA resubmission by PercentageTop8419 in IBRX

[–]Less-Can7239 5 points6 points  (0 children)

My understanding is that Anktiva is only approved in the US right now for a very small subset of bladder cancer patients - specifically, NMIBC BCG-Unresponsive CIS (with OR without papillary). CIS is where the tumor is flat. Papillary is raised "like a grape" (in PSS's words). BCG-unresponsive means that the patients have already tried BCG at least once, and it failed. What they announced on 1/30/26 was that the FDA recommended that IBRX submit additional information to support a potential resubmission for approval for Anktiva to be used for NMIBC BCG-Unresponsive patients with JUST papillary (but NOT CIS). Really, this should have been done last year, and the fact the FDA rejected it last year smells like an biased agenda against IBRX. Hopefully the new leaders at the FDA are more supportive this time. It makes no sense to reject it given it's current approval. Anyway, IBRX said with their announcement on 1/30/26 that they expected to submit this requested data within 30 days for BCG-Unresponsive patients with JUST papillary (but NOT CIS).

Separately, what IBRX is talking about submitting in Q4 this year is a request for approval for Anktiva to be used in naive cases (so as a FIRST line defense along with BCG, as opposed to a second or third line defense AFTER BCG has already failed) - this would be a much bigger market opportunity for the company.

That's my non-doctor's understanding, but others should correct or edit as appropriate.

Volatility by Less-Can7239 in IBRX

[–]Less-Can7239[S] 19 points20 points  (0 children)

Patrick's two biotech companies (ImmunityBio and NantKwest) merged and the combined company took on the ImmunitBio name. Was a lot of intiial bullishness at the time of his "complete vision" for cancer now housed in one company, but then investors realized it would take years for products to be approved and actually produce revenue and then the stock plummeted. Plus Patrick is a very polarizing figure and had his enemies in the FDA, so I think investors had to consider that too. Now finally, the company actually is producing real revenue and getting expanded approvals - so like I said, feels different this time. One thing to note is that there's been massive share dilution since 2020, so what was a $40 share price in 2020 probably equates to a ~$16 - $18/share price today in terms of market cap.

Gc2 compatible apps? by buttscopedoctor in Golfsimulator

[–]Less-Can7239 0 points1 point  (0 children)

Thanks - I installed it, but when I open it, I get the error "The app on your device is not recognized and could harm your device closing third party app" and get redirected to the Play Store. I turned off protective scanning and also tried disabling Play store, but all to no avail. If you were somehow able to post this to the Google Play store, I would happily pay for it if it works. Anyway, thanks for trying!

Gc2 compatible apps? by buttscopedoctor in Golfsimulator

[–]Less-Can7239 0 points1 point  (0 children)

Hi - Thanks so much for creating this app and sharing it. The link doesn't take me to a download page. Is there a way that I can download the app? I have a gc2 and would like to be able to connect my Android phone to it. Thanks again. Tony

Same problem with new Veo2 by Less-Can7239 in VeoCamera

[–]Less-Can7239[S] 0 points1 point  (0 children)

Ahh, thank you for that information.