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06 August 2021
06:20 hour

SPPI ???????????? some DD on this South Korean biotech’s fat duse

Reddit Stock Market

05/06/2021 - 07:43

SPPI (Spectrum Pharmaceuticals, Inc.) $3.95 (6/4/21) Market Cap over $554 million Average Volume over 2.8 million This DD will focus on SPPI’s phase 3 drug Rolontis. SPPI filed for its BLA in December of 2019 with a PFUDA date in October 2020. At that time, the FDA informed the company that an inspection of SPPI’s Hanmi Bioplant was required before they could approve the BLA. However, travel restrictions due to the ‘Rona pandemic prevented this inspection from occurring. Only until March of this year did the FDA schedule a pre-approval inspection in May and along with encouraging news of another SPPI drug Poziotinib in Phase 2 (not discussed here), it was announced on June 1 that the FDA was on site in Hanmi and the inspection had been initiated. Now why does this matter? Let a pacifier puffing baby in a crib enlighten you, if for only a moment. Rolontis treats chemotherapy-induced neutropenia. Cancer patients are often treated with chemotherapy. Chemotherapy, as you may know, often kills healthy cells along with the actual cancerous cells in one’s body. Some of these healthy cells that are killed are white blood cells. Having fewer than normal white blood cells is known as Neutropenia. White blood cells are essential for protection against foreign germs and therefore with fewer in the bloodstream, patients with Neutropenia are more susceptible to infection. A study done between 2009 and 2011 on 291 gynecological cancer patients, of whom the average age was 60, found that chemotherapy induced Neutropenia occurred in 50.5% of the patients. Each year, about 650,000 people are treated with chemotherapy and in 2012, over 100,000 people with cancer were hospitalized due to Neutropenia. Neutropenia can be fatal as well. On average, 4000 die each year of neutropenia with fever. Rolontis has proven more effective than the existing treatment, Pegfilgrastim, in treating neutropenia. The actual efficacy of Rolontis can be read from a publication that is linked below that I will not even attempt to translate. I, in agreement with Lee Schwartzberg smarty pants, foresee Rolontis improving supportive care for patients undergoing chemotherapy. I also foresee with my undeveloped mind that SPPI will consequently bring in that dough. This is of course not financial advice, no matter what the Karen’s think. I am simply a kid in a crib with unwieldy access to the internet. Rolontis, its efficacy and superiority over Pegfilgrastim: https://www.sppirx.com/338-spectrum-products-development-rolontis.html https://www.biospace.com/article/releases/spectrum-pharmaceuticals-announces-integrated-results-from-two-phase-3-rolontis-eflapegrastim-trials-being-presented-at-the-asco-annual-meeting/ Relevance and study of neutropenia: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4588600/ https://www.cdc.gov/cancer/dcpc/research/articles/neutropenia.htm https://www.cdc.gov/cancer/preventinfections/providers.htm   submitted by   /u/Manlius_Torquatus [link]   [comments]


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