As a recap of sorts, yesterday I asked about the a

As a recap of sorts, yesterday I asked about the anticipated approval timeline for HIV Monotherapy and received these helpful responses (see below).

I really appreciate all of these replies as I am relatively new here, however I am left wondering if Mono approval will require a time-consuming Pivotal Trial, or if it will happen on an expedited basis as a Label Expansion.

If anyone has a communication channel with Dr. NP, I think we'd all benefit from knowing the answer, especially because I seem to remember Gilead not being interested in Combo, but being very interested in Mono. I would expect that any other potential licensee/partner/acquirer would have a similar attitude.

Thanks in advance.




I wrote:

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I know this is not a front-burner topic, but do we have any sense of the general timing of a potential Monotherapy approval?

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Sunclouds wrote:

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There still play needs to be a pivotal phase 3 trial. If i am remembering it correctly, The protocol has been submitted and the fda asked for a meeting to discuss this it which still has not occurred therefore no enrollment in the phase 3 trial yet. Approval or a way off.

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sjacobs26 wrote:

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A lot of unknowns as this really hasn't been discussed much lately with everything else going on.
Based on previous comments, I expect the trial itself to be about a year as NP laid out in mid-2019. At this point unless the FDA throws them a bone (which I don't expect), IMO best case scenario will be 18 months after they begin recruiting.

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misiu143 wrote:

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I believe we will know when protocol is approved and study starting..
But as a optimistic person I still hope that FDA will forget about pivotal study and approve mono with combo, and this is why they were asking for documents of all 595 patients..
I just don't see any reason to have this only for combo...

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jk1550 wrote:

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Do shareholders know how much he saved the company by somehow having the FDA NOT demand a new study on a mono indication? Really eh?

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Ohm20 wrote:

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From Webinar 3/19/2020
03:48 Nader Pourhassan - Monotherapy was the first time that the single agent antibody that was self-injectable at home was tested and the results got better and better where the FDA agreed to look at a pivotal clinical trial and consider that for final approval after the first approval so it will be expanded label.

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ClosetInvestor wrote:

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Does this mean CYDY can/will attempt to use the most recent Mono trial of 550+ patients to file for a label extension? Or does CYDY still need to conduct another 48 week, costly Mono trial and then file for label extension?

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Ohm20 wrote:

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If another phase 3 trial was required then it would be its own approval not a label extension.

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ClosetInvestor wrote:

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So your under the assumption that CYDY will wait for combo to be approved and then file a label expansion for mono therapy using the data from the most recent mono pivotal trial?
Honestly, I like that idea much better than another 48 week mono trial. What I’m not sure of is if CYDY and the FDA are in the same boat. NP said in Dec or Jan that the new mono therapy trial was on hold as the main effort was the combo BLA and cancer, but I never interpreted as what you’re saying here.
I think this would be a good question for someone to ask NP during the next CC or webcast he does. Or maybe someone who emails him regularly can ask him.

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ClosetInvestor wrote:

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Do any of the other board members have an opinion on Ohm’s thought that CYDY can submit data from the most recent mono trial to the FDA for approval as a label expansion once combo is approved?

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misiu143 wrote:

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Yes, since I learned that FDA want records of ALL 595 patients in mono.
This is also mine opinion...How this could be needed only for combo ??
But no one is sure with FDA , so we will need to wait and see , but this is also mine opinion...

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Cytodynamite wrote:

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Keeping in mind how FDA treats us, it is ridiculous to believe they would give us mono approval without massive delay.

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gestalt2 wrote:

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Going to the way-back machine to recall how this whole combo trial got formed, It was a big win for the FDA to allow us to use safety data from the investigation Mono trial for the pivotal Combo trial. It meant that the Combo trial did not need the much larger population of patients to get to BLA. I don't think the same win can be used to justify the possibility the same safety data could result in a Mono approval without a pivotal trial.
I have not heard any possibility that a mono pivotal trial will not be required, just that the size of the trial could also be small and short because of the Combo trials/approval. I think they refer to it and a label expansion because it is the same use and same drug, so this is an addition to a previous approval.
However, last year when the investigation trial was taking place, there was rumors/discussions that the FDA could convert the investigation into pivotal. It seems like this faded away, and it is likely because the FDA likes a trial that sticks to a protocol and the data supports that protocol. Investigation trials tend to have modifications as data educates how the drug works. It could still happen and the size and detail of the Combo BLA might be an indicator that the FDA is looking at Mono approval, but it would be a surprise if so.

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ohm20 wrote:

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Going to the way-way -back machine. Monotherapy trials were running for years then the FDA decided Pro 140 needed a combo trial approved before they would consider approval in monotherapy.

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