GBA Presents: RADIO SAVANT-!

No you're just off. Go back and read my market summery. It explained where we are at. Then go back further and read my trading ranges -you are smack in the middle. If you like go and see where we made an upwards call on the S&P and made 70 points but the stocks reversed and you said I had the market direction wrong...

Now you wake up and see I was right all along, but you can't take away those nasty things you said.

Go back to sleep.
It's easy to be "right all along" when you change your tune daily.
:p
 
Omg.... we gotta have msnbc covering the Brits all morning like it was the friggin' OJ chase?!
As I type they are updating the fate of her Corgi's.
Pretty sure they'll be just fine. :banghead:

Isn't today 9/11?
>>>"Never Forget!" <<<
 
I wish they would talk a little more about the Queen's favorite horse.-

Burmese, born in Saskatchewan and trained in Ottawa, might have even saved her life when an assassin opened fire in 1981 in London

 
Van I read this a few times it's not making a ton of sense to me. 14 patients is small trial.
It's better to have up over 100. G778 mutations I have to look into.. it sounds like you have to have the HER 2 mutation to be successful that greatly reduces the patient pool.

I'd stay away fro now.

Spectrum announces data from poster presentation for Poziotinib at ESMO 13:11 SPPI Spectrum Pharmaceuticals announced data from a poster presentation titled: High Activity of Poziotinib in G778_P780dup HER2 Exon 20 Insertion Mutations in Non-Small Cell Lung Cancer. The data show that poziotinib is highly active in G778 mutations in both treatment naive and previously treated patients with NSCLC. The findings are based on an assessment of the activity of poziotinib in patients with the G778_P780dup HER2 exon 20 insertion mutation in a population of previously treated and treatment-naive patients with NSCLC from the ZENITH20 clinical trial. Patients in Cohort 2 received 16 mg of poziotinib once a day and patients in Cohort 4 received 16 mg QD or 8 mg twice a day. The primary endpoint was objective response rate. Fourteen patients had the HER2 G778 insertion mutation. 12 of 14 patients were evaluable and all had partial response, resulting in an ORR of 85.7% and a median DOR of 5.5 months. The ORR was 100% in the previously treated C2 patients, and 71.4% in the treatment naive C4 patients. Median DOR was 5.3 months for the C2 patients and 8.9 months for those in C4. The frequency of adverse events was consistent with prior reports and overall AEs were similar to the TKI class.
That's one of their pipeline drugs.

ROLVEDON™ is the one that just got approved.

Phase 3 had 643 patients:

"which evaluated the safety and efficacy of ROLVEDON in 643 early-stage breast cancer patients for the management of neutropenia due to myelosuppressive chemotherapy."

https://www.sppirx.com/300-spectrum-products-portfolio.html
 
On the regulatory front, we expect the US Inflation Reduction Act should provide significant upside to Fluence in the coming years. One of the key provisions of the bill is a 30% standalone storage investment tax credit. We also see other benefits resulting from the bill, which I will discuss shortly. As a reminder, our financial plans have not assumed these tax credits or other incentives. As we announced earlier this month, we have established a contract manufacturing location in Utah, which is expected to start production in late September. This will enable us to finalize assembly of our products here in the United States, closer to our customer sites. This will also allow us to avoid some of the supply chain issues we have encountered in other locations. More importantly, we expect to be able to capitalize on some of the incentives provided under the Inflation Reduction Act for our Utah facility.
 
new CEO-

Julian Nebreda

Thank you, Manuel. It is an honor and a privilege to be here with you today. Although I do not become CEO until September 1st, I thought I would share with you a bit about my background and my initial thoughts and priorities for Fluence. I'm not new to the Fluence family as I have been involved with the company since its creation and have been on the Fluence Board for the past year. For the past 23 years, I have served around the globe in different leadership roles for AES. Most recently, I was President of AES U.S. and global business lines. I have a kin interest and experience in growing renewable businesses. And I am proud to have led AES Europe when we introduced the first battery and e-storage projects units there. I have a good understanding of the key issues for Fluence from my role as a director. Although I'm still getting up to speed on the details of Fluence day-to-day operations, at this time, I do not foresee any major changes to Fluence strategy.
 
That's one of their pipeline drugs.

ROLVEDON™ is the one that just got approved.

Phase 3 had 643 patients:

"which evaluated the safety and efficacy of ROLVEDON in 643 early-stage breast cancer patients for the management of neutropenia due to myelosuppressive chemotherapy."

https://www.sppirx.com/300-spectrum-products-portfolio.html




Oh that one -- very toxic. It doesn't cure cancer it's just for infections and for less infection you get--

YOUR SPLEEN RUPTURED!>

Spleen rupture o_O

  • Splenic rupture, including fatal cases, may occur following administration of recombinant human granulocyte colony-stimulating factor (rhG-CSF) products. Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.
Acute Respiratory Distress Syndrome (ARDS)- Oh good that's fun o_O

  • ARDS may occur in patients receiving rhG-CSF products. Evaluate patients who develop fever, pulmonary infiltrates, or respiratory distress. Discontinue ROLVEDON in patients with ARDS.
Severe allergic reactions - Why Not! o_O

  • Serious allergic reactions, including anaphylaxis, may occur in patients receiving rhG-CSF products. Permanently discontinue ROLVEDON in patients who experience severe allergic reactions.
Sickle cell crisis in patients with sickle cell disorders

Glomerulonephritis- I have no idea but bring it on!

  • Glomerulonephritis has occurred in patients receiving rhG-CSF products. Diagnoses were based on azotaemia, hematuria (microscopic and macroscopic), proteinuria and renal biopsy. Events of glomerulonephritis generally resolved after dose reduction or discontinuation. Evaluate and consider dose reduction or discontinuation of ROLVEDON if causality is likely.
Leukocytosis

Thrombocytopenia

Capillary leak syndrome-> of course!

  • Capillary leak syndrome has been reported following administration of rhG-CSF products and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Episodes vary in frequency and severity and can be life-threatening if treatment is delayed. If symptoms develop, monitor closely and provide standard symptomatic treatment, which may include the need for intensive care.
Potential for tumor growth-stimulating effects on malignant cells<-- WHAT!!!!!!

  • The granulocyte colony-stimulating factor (G-CSF) receptor through which ROLVEDON works has been found on tumor cell lines. The possibility that ROLVEDON acts as a growth factor for any tumor type, including myeloid malignancy and myelodysplasia, diseases for which ROLVEDON is not approved, cannot be excluded.
Christ no infection but sorry your breast cancer is much worse now....
Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) in patients with breast and lung cancer

Aortitis

  • Aortitis has been reported in patients receiving rhG-CSF products. It can occur as early as the first week after starting treatment. Consider aortitis in patients who develop generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and elevated inflammatory markers (eg, c-reactive protein and white blood cell count) without known etiology. Discontinue ROLVEDON if aortitis is suspected.
Nuclear imaging

Side effects

  • The most common adverse reactions (≥20%) were fatigue, nausea, diarrhea, bone pain, headache, pyrexia, anemia, rash, myalgia, arthralgia, and back pain.
back pain too... no.:(
 
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