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We were close in the prior post! sickle cell actually doesn't appear delayed whereas beta thal does. Sorry, read it quick and I'm post nights. I admire them coming out and being honest, though I suspect they'll get slaughtered for it. Some of these bad actor CRSPR companies are going to get caught with their pants down.


From their IR email:
.......

bluebird bio Provides Assessment of Impact of COVID-19, Update on Business Operations and Clinical Program Development
- Company to hold investor conference call today, March 26, 2020 at 8:30 am ET –

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Mar. 26, 2020-- bluebird bio, Inc. (NASDAQ: BLUE) today provided an update in response to the global COVID-19 pandemic. The company has taken steps to ensure the safety of its patients and employees, while working to ensure the sustainability of its business operations as this unprecedented situation continues to evolve.

“The COVID-19 pandemic has created new challenges for bluebird, the broader biotech community, and society as a whole. During this unprecedented time, we remain focused on caring for the patients who rely on us,” said Nick Leschly, chief bluebird. “In addition, we are prioritizing the safety and well-being of our employees, making a positive impact as a member of our local community, and continuing to execute on our business strategy. While we all face tremendous challenges and uncertainty at this time, I am confident in bluebird’s ability to face these headwinds with ingenuity, empathy, and a relentless commitment to the people we serve.”

bluebird bio continues to evaluate the impact of COVID-19 on the healthcare system and work with healthcare providers supporting its clinical studies to mitigate risk to patients while taking into account regulatory, institutional, and government guidance and policies. The company remains committed to maintaining its development plans but acknowledges the potential impact on clinical studies given the rapidly evolving global environment. Generally, the company expects the COVID-19 pandemic to shift the timing of enrollment and completion of clinical studies by at least three months and expects timing shifts to vary by clinical trial and by program.

Regulatory Activities

Ide-cel (bb2121): In partnership with Bristol-Myers Squibb (BMS), the companies’ previously announced plans to submit the U.S. Biologics License Application (BLA) for ide-cel in the first half of 2020 remain on track. The clinical trials that form the basis for this application have completed enrollment.
LentiGlobin for ß-thalassemia: As part of the rolling BLA submission for LentiGlobin for ß-thalassemia, the company has been engaged in discussions with the U.S. Food and Drug Administration (FDA) regarding the requirements and timing of certain information related to release assays that would be provided as part of its rolling BLA submission. These assays are advancing through development and validation for use in the commercial setting and are likely to be impacted by the COVID-19 situation.
Additionally, based on continued and ongoing discussions with the FDA in the context of bluebird bio’s Fast Track and Breakthrough Therapy designations, the company and the FDA have not been able to agree on bluebird bio providing data regarding these assays to the FDA during review of the BLA. Based on the status of these ongoing discussions and the expected COVID-19 related shifts, bluebird bio does not anticipate completing the rolling BLA submission for LentiGlobin for ß-thalassemia until mid-2021 (Q2/Q3). If completion of the BLA for LentiGlobin for ß-thalassemia is shifted until mid-2021, bluebird bio may have the opportunity to seek approval for a broader patient population, including patients with ß0/ß0 genotypes in addition to pediatric patients.
Lenti-D for Cerebral Adrenoleukodystrophy (CALD): bluebird bio is currently on track to submit the Marketing Authorization Application (MAA) in the EU for Lenti-D for CALD by year-end 2020. Based on the implications of our recent discussions with the FDA on LentiGlobin for ß-thalassemia and the impacts of the COVID-19 pandemic on the business, the company now estimates that it will be able to submit the BLA for Lenti-D in CALD in mid-2021.
LentiGlobin for Sickle Cell Disease (SCD): bluebird bio continues to engage in discussions with the FDA about the regulatory path for LentiGlobin for SCD. The company reiterates guidance for a regulatory update by the end of 2020.
Commercial Launch of ZYNTEGLO®

In January 2020, the company announced the availability of ZYNTEGLO™ in Germany. While the process of consenting, preparing, and treating patients with ZYNTEGLO in Germany remains ongoing, given the evolving COVID-19 situation, the company expects the treatment of the first commercial patient in Germany to be shifted to the second half of 2020.
During this time, bluebird bio plans to continue to engage in reimbursement discussions and undertake commercial preparation activities in the priority launch markets in Europe. The company expects the COVID-19 pandemic to impact its ability to achieve market access and reimbursement in Europe.
Operating Plan
In light of the impacts of the COVID-19 pandemic on the business and the anticipated changes to commercial, regulatory and development timelines, the company is currently re-evaluating its operating plan. The company will be adjusting priorities and overall expenses. An update will be provided by the company’s Q1 2020 earnings release.

Ongoing Programs and Clinical Studies
Below is the current status of bluebird bio sponsored clinical trials:

Ongoing clinical studies of LentiGlobin for ß-thalassemia, LentiGlobin for SCD, Lenti-D for CALD as well as the study of bb21217 for multiple myeloma all currently remain active, but the effects of the COVID-19 pandemic is resulting in disruptions to study conduct across these programs.
The company has provided new guidance to investigators for all clinical studies in response to the COVID-19 pandemic to ensure extra precautions and communications are in place.
As our partner in development of ide-cel, BMS has disclosed, it has have temporarily suspended screening, enrollment and apheresis in their cellular therapy clinical studies, which includes the KarMMa-2, KarMMa-3 and KarMMa-4 studies. The decision to temporarily suspend further screening, enrollment and apheresis is not considered an urgent safety measure and does not impact the ongoing BLA activities with the FDA for ide-cel.
Planned data disclosures for 2020 remain on track

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http://investor.bluebirdbio.com/news-releases/news-release-d...
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