With the overlap, my guess is the FDA will require
Post# of 153776
(Total Views: 245)
Posted On: 04/17/2019 3:05:58 PM
Re: Nt2innvovate #2109
With the overlap, my guess is the FDA will require all new patients for clean data.
The company has been punished in my opinion in trying to do the combo trial and mono trial at the same time. The FDA has been requiring more safety data than for IZ for example, because CYDY is attempting to go the mono route. So they can ask for data from the mono trial, where they didn't for IZ because there was no mono trial. If they had just went combo only until approval and then mono, the combo would be approved now in my opinion. (But we would be at square one with mono right now as a big unknown.)
Also the FDA changing their minds on the safety data several times now has cost shareholders time and money. If the FDA hadn't have asked for 300 patients on safety data in 2017, no way would CYDY have pushed mono enrollment so hard at 350mg. They could have taken their time and discovered to escalate the dose way before enrolling 150 patients at 350mg. Then the FDA isn't even allowing those 150 patients to be considered, since they want 700mg safety data again looking at the results from the mono trial (which they would never had gotten if combo finished first).
This latest change from safety data requirement at 700mg has brought the company a very difficult place, because the BLA submission would be behind us now, probably financial issues as well. With that change the FDA requested, some are blaming NP, saying he lied, etc. Very tough spot to be in, basically asking for 6 more months delay right when we were expecting to be done.
In the 10Q they said they may discontinue the old mono trial upon approval of new.
The company has been punished in my opinion in trying to do the combo trial and mono trial at the same time. The FDA has been requiring more safety data than for IZ for example, because CYDY is attempting to go the mono route. So they can ask for data from the mono trial, where they didn't for IZ because there was no mono trial. If they had just went combo only until approval and then mono, the combo would be approved now in my opinion. (But we would be at square one with mono right now as a big unknown.)
Also the FDA changing their minds on the safety data several times now has cost shareholders time and money. If the FDA hadn't have asked for 300 patients on safety data in 2017, no way would CYDY have pushed mono enrollment so hard at 350mg. They could have taken their time and discovered to escalate the dose way before enrolling 150 patients at 350mg. Then the FDA isn't even allowing those 150 patients to be considered, since they want 700mg safety data again looking at the results from the mono trial (which they would never had gotten if combo finished first).
This latest change from safety data requirement at 700mg has brought the company a very difficult place, because the BLA submission would be behind us now, probably financial issues as well. With that change the FDA requested, some are blaming NP, saying he lied, etc. Very tough spot to be in, basically asking for 6 more months delay right when we were expecting to be done.
In the 10Q they said they may discontinue the old mono trial upon approval of new.
Quote:
. Subject to the continuation of a high responders’ rate from preliminary data from the 525 mg and 700 mg dose arms, this trial may be discontinued, if and when we successfully file a protocol for a pivotal Phase 3 trial for monotherapy and initiate such a trial.
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