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BioCryst Pharmaceuticals, Inc. Message Board

maphere 132 posts  |  Last Activity: 1 minute 0 seconds ago Member since: Sep 17, 2007
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  • maphere by maphere 1 minute 0 seconds ago Flag

    From NATURE, June 3, 2015:

    "It is good news, then, that plans to improve global disease response are in the pipeline, and could be announced as soon as this weekend. Prepared under the leadership of Germany’s Chancellor Angela Merkel, the proposals are expected to be presented at the annual summit of the G7 group of leading industrialized countries, due to take place in Elmau, Germany, on 7–8 June. The package of measures is a promising sign that politicians at the highest level take the threat of infectious disease seriously, and it lays out some sensible suggestions."

    ...Another welcome proposal is to speed up trials by developing protocols and experimental designs before outbreaks occur, and to have these pre-approved by regulators, so that when there is an outbreak, trials could start immediately.

  • Reply to

    MERS Cluster: South Korea

    by maphere May 26, 2015 2:38 PM
    maphere maphere 4 minutes 54 seconds ago Flag

    South Korea - Government announces 5 more coronavirus MERS cases, including 2 more health care workers - total now 35 - June 3, 2015
    ________________

    Guys, I realize this is an "outlier" but as this MERS cluster grows it will pick up speed and gain more attention. Already WHO has a convoy investigating, they don't want to make the same mistake they admitted to with Ebola by waiting too long to proactively respond.

    REMEMBER...there are no treatments for MERS and there's already discussion of it mutating based on the spread in SK. Not to consider BCX4430 for NHP testing is inexcusable.

    FORBES QUOTE (4/24/14):

    "Amazingly, in vitro experiments showed that BCX4430 could potentially work against a wide range of viruses, including SARS, MERS, influenza, dengue, and measles.

    Because no human clinical trials have yet been conducted, it’s still far too early to pop the cork on our champagne bottle. But this antiviral holds the greatest potential for curing nightmarish hemorrhagic fevers."

  • Great post Husky...I've followed them since 09 about as intently as an investor can follow a company and I'm so impressed with the open to communication that has been provided me by Rob (IR) as well as Jon Stonehouse.

  • Reply to

    4161 now 33 trial sites...plus

    by maphere Jun 2, 2015 3:32 PM
    maphere maphere Jun 2, 2015 4:07 PM Flag

    If this was Sept. I might think so.

  • Canada added as Health Authority

    Here's the list of other countries:

    United States: Food and Drug Administration
    Germany: Federal Institute for Drugs and Medical Devices
    United Kingdom: Medicines and Healthcare Products Regulatory Agency
    France: Agence Nationale de Sécurité du Médicament et des produits de santé
    Italy: The Italian Medicines Agency
    Hungary: National Institute of Pharmacy
    Belgium: Federal Agency for Medicines and Health Products, FAMHP
    Canada: Health Canada

  • Reply to

    MERS Cluster: South Korea

    by maphere May 26, 2015 2:38 PM
    maphere maphere Jun 2, 2015 2:01 PM Flag

    South Korea - Ministry of Health announces 5 new coronavirus MERS cases - cumulative total now equals 30 - June 2, 2015
    __________

    CDC

    Treatment
    There is no specific antiviral treatment recommended for MERS-CoV infection.

    Is there a vaccine?

    A: Currently, there is no vaccine available to protect against MERS.
    ________________

    Ebola this time last year was starting to create concern, by August govts. were scrambling for answers.

    30 Mers patients from one traveler, 3 of them are 3rd generation affected. ~700 people quarantined.

    BCX4430 about done with safety trial putting it much further along than it was for Ebola.

  • Reply to

    MERS Cluster: South Korea

    by maphere May 26, 2015 2:38 PM
    maphere maphere Jun 1, 2015 5:09 PM Flag

    The new cases included the country's first tertiary infections as two people were found to have contracted the virus from a secondarily-infected patient.
    __________

    FYI, had this happened in the US it would be a huge story. The ebola quandary exposed the lack of treatments for that disease and forced the US and other govts. to rush early treatments.

    A US cluster would further demonstrate the slowness of moving MCM drugs towards approval...

    .BCX4430 has been in PH1 since mid December requiring 88 patients to demonstrate safety. This trial should have been completed. HHS has likely seen early safety results since they took the baton from NIAID to further 4430 but BCRX has been kept quiet.

    Since 4430 is broad spectrum, and shown invitro efficacy against MERS, it would stand to reason that there have been discussions about it as a candidate. Now where are the NHP trials on 4430 against MERS?

  • Reply to

    MERS Cluster: South Korea

    by maphere May 26, 2015 2:38 PM
    maphere maphere Jun 1, 2015 4:00 PM Flag

    South Korea - Government reports 7 more confirmed coronavirus MERS cases - including 2 deaths - total is now 25 - June 1, 2015

  • Reply to

    hmmm…

    by huskys4u2 May 29, 2015 12:40 PM
    maphere maphere Jun 1, 2015 2:37 PM Flag

    "never thought that oppy had that kind of pull…"

    Husky, JPM said this April 3:

    "...the firm thinks that BioCryst's stock can rise significantly heading into key catalysts in the second half of the year and kept an Overweight rating on the name."

    ____________

    JPM PT is $18

  • maphere maphere Jun 1, 2015 1:31 PM Flag

    No longer listed at BCRX website...assume they filled this position (that was quick).

    NEW ONE added today:
    ________________
    Department: Clinical Operations
    Job Title: Clinical Study Manager
    Job Location: Durham, NC
    Description:
    The Clinical Development Manager manages global clinical studies for one or more product candidates, with one or more indications, from early development to regulatory approval (Phase 1-3) and beyond, in order to achieve a high quality product for the marketplace and business success for company. This involves participation in all aspects of study design, execution, analysis and reporting, including critical document design (protocol, CRF, data management plan, statistical analysis plan, clinical study report), vendor selection and management, oversight of investigator selection, study conduct and site monitoring, data collection, analysis planning and reporting, managing clinical supplies, quality control, and study budget development and tracking to ensure compliance with regulatory and ICH/FDA GCP guidelines.

  • Reply to

    hmmm…

    by huskys4u2 May 29, 2015 12:40 PM
    maphere maphere Jun 1, 2015 12:17 PM Flag

    I think money is coming out of DYAX into BCRX to represent a truer value for Biocryst.

  • Reply to

    MERS Cluster: South Korea

    by maphere May 26, 2015 2:38 PM
    maphere maphere Jun 1, 2015 10:27 AM Flag

    13) #1173 - Male, 35, hospitalized May 13 for TB, on same ward as case #1149, re-hospitalized May 27, South Korea WHO

    14) #1174 - Male, 35, onset May 24, hospitalized May 25-27, son of previous case, South Korea WHO

    15) #1180 - Male, 49, onset May 21, husband of case #1172, South Korea WHO

    16) #1181 - MoH confirmed: reportedly a male, 40, on ward with case #1149, South Korea

    17) #1182 - MoH confirmed: reportedly a male, 45, son of case on ward with case #1149, South Korea

    18) #1183 - MoH confirmed, reportedly a female, 77, on ward with case #1149, South Korea

    _____________

    NCBI 2/2015

    "BCX4430 is not only active against Ebola virus, but also targets other members of the Filovirus family as well as 8 other RNA virus families. Because of the potent and efficacious effects, BCX4430 is being fast-tracked for clinical trials in humans."

  • Reply to

    MERS Cluster: South Korea

    by maphere May 26, 2015 2:38 PM
    maphere maphere May 29, 2015 11:22 AM Flag

    11) #1171 - Hospitalized contact of previous case, announced May 29, South Korea

    12) #1172 - Hospitalized contact of previous case, announced May 29, South Korea

    and...

    A Hong Kong woman was rushed to hospital today showing symptoms of deadly Middle East respiratory syndrome (Mers) after she shared a flight to the city with a Korean man confirmed to have the virus.

  • Reply to

    MERS Cluster: South Korea

    by maphere May 26, 2015 2:38 PM
    maphere maphere May 29, 2015 10:03 AM Flag

    and now there was 10 including the one that got away to China:

    1) #1149 - IMPORTED CASE/INDEX CASE - Male, 68, onset May 11, hospitalized in South Korea May 15 & May 20, travel history to Gulf, Bahrain/Saudi Arabia/UAE/Qatar WHO

    2) #1151 - Female, 63, wife of case #1149, South Korea WHO

    3) #1152 - Male, 76, hospital roommate of case #1149, South Korea WHO

    4) #1158 - Female, 46, daughter of case #1152 & contact of case #1149, South Korea

    5) #1160 - Male, 50, doctor, contact of case #1149 for less than 1 hour, South Korea

    6) #1161 - Male, 71, contact with case #1149, hospitalized, South Korea

    7) #1162 - Female, 28, contact with case #1149, hospitalized, South Korea

    8) #1165 - Medical staff, contact with case #1149, South Korea

    9) #1166 - Shared hospital room with case #1149, South Korea

    10) #1167 - EXPORTED CASE - Male, 44, brother of case #1158, son of case # 1152, traveled to Guangdong, China via Hong Kong, South Korea

  • Reply to

    MERS Cluster: South Korea

    by maphere May 26, 2015 2:38 PM
    maphere maphere May 28, 2015 10:50 AM Flag

    South Korea confirms 6th & 7th coronavirus MERS cases - May 28, 2015

    and...

    The Health Ministry said the son of the second confirmed victim in the outbreak, who was himself being observed for possible infection, broke voluntary home quarantine and left South Korea on Tuesday for China.

    The 44-year-old man expressed discomfort as early as May 21 and reported fever of 38.7 degree celsius on Monday. He landed in Hong Kong on Tuesday and went on to Huizhou city in Guangdong Province via Shenzhen.

    Chinese state broadcaster CCTV said that authorities in Guangdong province found the Korean man on Thursday and isolated him in a hospital for treatment. They also isolated 35 people who had come in close contact with him, though none has yet to shown symptoms.

    The man had not exhibited symptoms other than a fever and had not been confirmed as a MERS case.

  • Reply to

    Sep 30 is a key date

    by left2rightdoor May 28, 2015 2:00 AM
    maphere maphere May 28, 2015 9:28 AM Flag

    Sept. 30 is the end of their FY:
    ________

    ASPR’s budget request to Congress for fiscal year
    (FY) 2015—which extends from October 1, 2014
    through September 30, 2015—supports our mission
    and reflects the goals and objectives of our
    five-year strategic plan as follows

    ____________

    We help make sure the country has the vaccines,
    drugs, and medical supplies our population may
    need in a disaster. And, when states ask for assistance,
    we are ready with a federal health response
    tailored to their needs.
    ___________

    Thanks to the
    efforts of BARDA and its partners, a dozen MCMs
    were added to the SNS during the last decade and
    more than 85 other MCM candidates are in the
    pipeline for further development and prospective
    procurement.

    The Administration’s goal is to
    add 12 new CBRN MCMs to the SNS by the end of
    FY 2018.

    The Pandemic and All-Hazards Preparedness
    Reauthorization Act (PAHPRA) authorizes up
    to $2.8 billion during FY 2014-2018 for BARDA to
    meet this goal.
    ___________

    My note: BCRX is happy to share in the 2.8 billion pie...

  • Reply to

    Coming up: Jeffries, JMP...JUNE

    by maphere May 20, 2015 3:27 PM
    maphere maphere May 27, 2015 10:58 AM Flag

    From Twitter:

    JPM" $BCRX Management Meeting Takeaways; Next Up: Ph I Data for Next Gen HAE Asset '7353;Expect data late 3Q,Maintain OW, TP=$18.

  • 4 people caught it from one patient returning from Middle East. Why so easily transferable in this situation and not in M.E.? BCX4430 hasn't been formally discussed for this disease but we know...

    "In addition, BCX4430 was shown to be active in vitro against a broad range of other RNA viruses, including the emerging viral pathogen Middle East Respiratory Syndrome Coronavirus (MERS-CoV)."

    MERS is like SARS, remember the concern SARS casued? Now we see a large cluster from MERS that was transferred from one person coming back from the M.E.

    Details below from flutrackers:
    _____________________________

    Current South Korea coronavirus MERS cluster:

    1) #1149 - Male, 68, onset May 11, hospitalized in South Korea May 15 & May 20, travel history to Gulf: Bahrain/Saudi Arabia/UAE/Qatar WHO

    2) #1152 - Female, wife of case #1149, South Korea WHO

    3) #1153 - Male, 76, hospital roommate of case #1149, South Korea WHO

    4) #1159 - Female, daughter of case #1153 & contact of case #1152, South Korea

    5) #1161 - Doctor, contact of previous case, South Korea

  • Reply to

    Coming up: Jeffries, JMP...JUNE

    by maphere May 20, 2015 3:27 PM
    maphere maphere May 21, 2015 11:32 AM Flag

    From flyonthewall:

    BioCryst management to meet with JPMorgan
    Meeting to be held in New York on May 21 hosted by JPMorgan.

  • (likely)

    Jefferies 2015 Global Healthcare Conference

    When: Mon, June 1, 2015, 8am – Thu, June 4, 2015, 5pm
    Where: New York City, NY

    JMP

    Tuesday, June 24, and Wednesday, June 25, 2014
    The Westin New York Grand Central

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