H1.66 could 1.5 be support? SPPI biopharmaceutica
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Posted On: 12/01/2021 1:18:27 PM
Re: AviseAnalytics #24
H1.66 could 1.5 be support?
SPPI biopharmaceutical company, received a Complete Response Letter (CRL) for the Biologics License Application (BLA) for ROLONTIS® (eflapegrastim). The CRL asked for a reinspection of the Company’s manufacturing facilities to address deficiencies in manufacturing. The Company is seeking further clarification from the FDA and seeking to gain a better understanding of the “remediation timelines for the program”.
ROLONTIS® (eflapegrastim) is a long-acting granulocyte colony-stimulating factor (G-CSF) for the treatment of neutropenia in patients receiving myelosuppressive anti-cancer drugs. The candidate has been evaluated in two phase 3 trials namely ADVANCE and RECOVER, and has demonstrated non-inferiority (NI) in duration of severe neutropenia (DSN) and similar safety profile to pegfilgrastim. The Company’s BLA application was deferred by the FDA in October 2020, as COVID-19 pandemic travel restrictions derailed its inspection plan of the Hanmi Bioplant in South Korea, ROLONTIS® (eflapegrastim) manufacturing site.
The Company’s poziotinib, an orally administered irreversible tyrosine kinase inhibitor that targets EGFR and HER2 mutations, intended for the treatment of non-small cell lung cancer (NSCLC) in previously treated patients with HER2 exon 20 mutations, was granted a fast-track designation by the FDA in March 2021, Spectrum is planning a new drug application later this year. The Company presented data at the European Society for Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Virtual Congress 2021, which showed that twice daily dosing (BID) improved anti-tumor activity and reduced toxicity compared to once daily dosing.
SPPI biopharmaceutical company, received a Complete Response Letter (CRL) for the Biologics License Application (BLA) for ROLONTIS® (eflapegrastim). The CRL asked for a reinspection of the Company’s manufacturing facilities to address deficiencies in manufacturing. The Company is seeking further clarification from the FDA and seeking to gain a better understanding of the “remediation timelines for the program”.
ROLONTIS® (eflapegrastim) is a long-acting granulocyte colony-stimulating factor (G-CSF) for the treatment of neutropenia in patients receiving myelosuppressive anti-cancer drugs. The candidate has been evaluated in two phase 3 trials namely ADVANCE and RECOVER, and has demonstrated non-inferiority (NI) in duration of severe neutropenia (DSN) and similar safety profile to pegfilgrastim. The Company’s BLA application was deferred by the FDA in October 2020, as COVID-19 pandemic travel restrictions derailed its inspection plan of the Hanmi Bioplant in South Korea, ROLONTIS® (eflapegrastim) manufacturing site.
The Company’s poziotinib, an orally administered irreversible tyrosine kinase inhibitor that targets EGFR and HER2 mutations, intended for the treatment of non-small cell lung cancer (NSCLC) in previously treated patients with HER2 exon 20 mutations, was granted a fast-track designation by the FDA in March 2021, Spectrum is planning a new drug application later this year. The Company presented data at the European Society for Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Virtual Congress 2021, which showed that twice daily dosing (BID) improved anti-tumor activity and reduced toxicity compared to once daily dosing.
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The majority of my post are the top 20% gainer! To decode them its (ticker ID, % Changed, Volume, Close price and Float) I typically put V,C&F as a prefix to that number and use K, M and B as a suffix (Kilo, Million & Billion) for volume and float. I may also use S for Support and R for Resistance.
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I (Znewcar1) do not provide personal investment advice and I am not a qualified licensed investment advisor. I am an amateur investor.
All information found here, including any ideas, opinions, views, predictions, forecasts, commentaries, suggestions, or stock picks, expressed or implied herein, are for informational, entertainment or educational purposes only and should not be construed as personal investment advice. While the information provided is believed to be accurate, it may include errors or inaccuracies.
I will not and cannot be held liable for any actions you take as a result of anything you read here.
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