From an iHub poster who contacted NP on Saturday a
Post# of 153887
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Posted On: 06/17/2019 11:25:43 AM
From an iHub poster who contacted NP on Saturday and received the response below (summarizes by the poster):
I emailed NP over the weekend with some of my concerns, and echoed some of the things I've read on this board. Surprisingly, he emailed me back last night. While he didn't respond to all of my questions/comments, he did touch on a few.
As far as the TNBC trial and first patient injected, he said he was also "disappointed" in the delay and said the "approval process and delays of the Institutional Review Board (IRB)really hurt us. The good news is we now have the IRB (onboard) and we are not changing our forecast of 1H2019 in this regard."
Regarding the BLA submission date slipping "In regards to the BLA, we are victim of our own success. When the Monotherapy success of more than 90% was announced, the FDA made us switch the approval of combination therapy for the higher dose, therefore the timelines changed since more data was requested (rightfully so). Again the good news is the 90% that we reported makes this company's future potential revenue in numbers that are incredibly high in every sense."
Lastly, CYDY will have a shareholders conference call "in a month or so and we will have quite a bit to update by then."
I emailed NP over the weekend with some of my concerns, and echoed some of the things I've read on this board. Surprisingly, he emailed me back last night. While he didn't respond to all of my questions/comments, he did touch on a few.
As far as the TNBC trial and first patient injected, he said he was also "disappointed" in the delay and said the "approval process and delays of the Institutional Review Board (IRB)really hurt us. The good news is we now have the IRB (onboard) and we are not changing our forecast of 1H2019 in this regard."
Regarding the BLA submission date slipping "In regards to the BLA, we are victim of our own success. When the Monotherapy success of more than 90% was announced, the FDA made us switch the approval of combination therapy for the higher dose, therefore the timelines changed since more data was requested (rightfully so). Again the good news is the 90% that we reported makes this company's future potential revenue in numbers that are incredibly high in every sense."
Lastly, CYDY will have a shareholders conference call "in a month or so and we will have quite a bit to update by then."
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