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Posted On: 04/19/2020 1:17:59 PM
Post# of 148903
Cycl2R,
BLA files probably next week. Is a rolling application and the clinical part has been iterated few times with FDA. Let's assume end of April. Decision 6 months .. that is later October. Some might argue that will be early than that.
I would think CYDY and Vyera will be getting ready for sales in the mean time. However, the SP will appreciate dramatically before the decision (most companies factor-in the most likely FDA decision BEFORE). As for the sales quantities, as with any product recently launched it will depend on promotion, inter-physician communication, scientific publications, etc. I assume also that a good quantity will be sold overseas as well.
The Mild-Moderate will be finished first. Say 2 weeks more for enrollment, 4 weeks end of trial. 2 weeks data crunching. Puts us middle-end June. If the results are good I think that FDA will be under an immense pressure to put the drug in the market really soon. Remember that Manufacturing would be already submitted (same for HIV) and clinical will be the only part missing for the CV application.
So imho, CV has a god shoot to be in the market before Combo (provided we get good results, of course), however I do believe that, all together, we will have revenue this year, and more importantly, the SP will appreciate substantially before this happens (as with any other Biotech). There are many examples out there with MCs much higher than CYDY's with less promising products and still many years away from BLA submission.
The above just estimations (mine). Obviously some will argue about different timing(s), which is understandable.
Quote:
On what revenues? Even if the BLA for combo is filed in May it could be approved if at all around Nov-Dec of this year.
BLA files probably next week. Is a rolling application and the clinical part has been iterated few times with FDA. Let's assume end of April. Decision 6 months .. that is later October. Some might argue that will be early than that.
Quote:
No time left for marketing it let alone selling in any meaningful quantities.
I would think CYDY and Vyera will be getting ready for sales in the mean time. However, the SP will appreciate dramatically before the decision (most companies factor-in the most likely FDA decision BEFORE). As for the sales quantities, as with any product recently launched it will depend on promotion, inter-physician communication, scientific publications, etc. I assume also that a good quantity will be sold overseas as well.
Quote:
The only other theoretical possibility is getting the CV indication approved sometime by the end of the summer, submitting the BLA (late fall) and getting it approved by the FDA in early 2021.
The Mild-Moderate will be finished first. Say 2 weeks more for enrollment, 4 weeks end of trial. 2 weeks data crunching. Puts us middle-end June. If the results are good I think that FDA will be under an immense pressure to put the drug in the market really soon. Remember that Manufacturing would be already submitted (same for HIV) and clinical will be the only part missing for the CV application.
So imho, CV has a god shoot to be in the market before Combo (provided we get good results, of course), however I do believe that, all together, we will have revenue this year, and more importantly, the SP will appreciate substantially before this happens (as with any other Biotech). There are many examples out there with MCs much higher than CYDY's with less promising products and still many years away from BLA submission.
The above just estimations (mine). Obviously some will argue about different timing(s), which is understandable.
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