The RTF communication is obviously not good news.
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Posted On: 07/13/2020 9:02:41 AM
The RTF communication is obviously not good news. And, having this information at hand we need to make the best decisions regarding our investment.
So, what happened?? without more information is difficult to make a definite statement. However, the key for me (with what we know right now) is in this:
The remarks below are based on this assumption (more data crunching required), I might be wrong on the interpretation of the communication.
It would seem that FDA wants more analysis of the data we have on patients results. This could be obtained rapidly and submitted to FDA as would entail just statistics + computer work.
Also, the FDA suggested the type A meeting where they will explain why they cannot perform a substantive review at this time so CYDY can “fill in the gaps”.The result of all this is a delay in the approval of the combination therapy.
So, what went wrong??? Well, if the data was previously available we can say that either FDA is being “as difficult as possible” for reasons that I better don’t get into, or, that AMAREX don’t have the required experience/expertise to file such a complex application and the information they provided was not adequately analyzed or presented.
It will be interesting to understand what was exactly the issue and how long it will take to respond to FDA queries. This evening we will get some color on all this.
As far as I am concerned we got a delay for HIV commercialization, but, apart from that nothing has changed.
Next couple of weeks will be potentially, very positive with the P2 lock-and unbind and the P3 DSMC analysis of our P3.
So, I am holding long and strong.
So, what happened?? without more information is difficult to make a definite statement. However, the key for me (with what we know right now) is in this:
Quote:
rather the Company will conduct additional analysis of completed trials.
The remarks below are based on this assumption (more data crunching required), I might be wrong on the interpretation of the communication.
It would seem that FDA wants more analysis of the data we have on patients results. This could be obtained rapidly and submitted to FDA as would entail just statistics + computer work.
Also, the FDA suggested the type A meeting where they will explain why they cannot perform a substantive review at this time so CYDY can “fill in the gaps”.The result of all this is a delay in the approval of the combination therapy.
So, what went wrong??? Well, if the data was previously available we can say that either FDA is being “as difficult as possible” for reasons that I better don’t get into, or, that AMAREX don’t have the required experience/expertise to file such a complex application and the information they provided was not adequately analyzed or presented.
It will be interesting to understand what was exactly the issue and how long it will take to respond to FDA queries. This evening we will get some color on all this.
As far as I am concerned we got a delay for HIV commercialization, but, apart from that nothing has changed.
Next couple of weeks will be potentially, very positive with the P2 lock-and unbind and the P3 DSMC analysis of our P3.
So, I am holding long and strong.
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