Since I wasn't a shareholder in early 2019 I was t
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Posted On: 04/18/2020 1:56:52 PM
Since I wasn't a shareholder in early 2019 I was trying to understand the importance of the final submission of the BLA application. There may be others in the same position.
In early 2019 they submitted some parts of the Biological License Application:
https://www.globenewswire.com/news-release/20...r-HIV.html
We are now waiting for the technical information of the BLA to be submitted. Based on the recent conference call, barring any unforeseen emergencies, the remainder of the technical information will be submitted by this Friday which completes the BLA application.
From what I have seen posted here, we would then wait approximately 6 months for the FDA to approve our license . Then we can sell our product. However, there is also the possibility of a delay if the FDA asks for additional information..
Is this a good summary or did I miss something. Apparently the mere filing of the complete BLA application normally is a very positive move for the company and it may trigger upward movement in the stock.
Thanks for your patience.
Thank you.
In early 2019 they submitted some parts of the Biological License Application:
https://www.globenewswire.com/news-release/20...r-HIV.html
We are now waiting for the technical information of the BLA to be submitted. Based on the recent conference call, barring any unforeseen emergencies, the remainder of the technical information will be submitted by this Friday which completes the BLA application.
From what I have seen posted here, we would then wait approximately 6 months for the FDA to approve our license . Then we can sell our product. However, there is also the possibility of a delay if the FDA asks for additional information..
Is this a good summary or did I miss something. Apparently the mere filing of the complete BLA application normally is a very positive move for the company and it may trigger upward movement in the stock.
Thanks for your patience.
Thank you.
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