RE:Comparing Corporate Presentations “Andre Uddin
Okay. That's great. And just -- and also just looking at the F8 formulation and the sterile water situation, once you do get consistent supply, what human study do you actually need to do? And about how long do you think that would take before you can then file an sBLA from when you start the study? Thank you.
Paul Levesque
Yes. Thank you. The human factor study that we have proactively decided to do with the F8 is identical as the one that is now required by the FDA on the F4. Christian, the methodology is very simple, right?
Christian Marsolais
Yes, it is simple and it is something we or our company that is the expertise in this field, then like it's a study that will be completed in time for submission. But I want also to address the other part of your question in terms of which study was done.
In terms of the bioequivalence, we have done the exact same thing as what was done for the F4, and that study is already completed and well, they have shown bioequivalence between the F8 and the F1 then this part of the trial is completed.
Andre Uddin
Okay. That's great. And but how long would that take about, do you think, to run that new study once you get...
Christian Marsolais
The human factor study that we're thinking about a period of about 12 months to run a study like this one because there's two parts. There's a part which is a formative part. After that, we need to get feedback from the FDA, which is about 70 days. And after that, we do what we call the SUMMIT of study and submit the results to the FDA, the 9 to 12 months to be completed.
Paul on NASH:
Now I'd like to provide an update on NASH. The NASH program is still on pause pending the sourcing of bacteriostatic water and the securing of a partner with resources and capabilities. After internal discussions and to further derisk the Phase III trial, the company has submitted an amended protocol to the FDA. The new protocol, a Phase 2b/3 seamless study design includes an interim analysis of the first 350 or so patients.
This data will be analyzed by a data monitoring committee to assess the efficacy of tesamorelin and will allow us to generate hard endpoint data on NAS score and fibrosis. A decision will then be made whether to continue the study until the full number of patients, 1094, have completed 18 months of treatment.
The FDA has agreed to this redesigned protocol. We continue to have discussion with potential NASH partners and are very encouraged to see renewed NASH interest and recent industry partnership announcement.”
So I lt doesn’t seem like F8 is off the table as they “proactively decided” to proceed with the Human factor study and already completed the in house bio equivalency study between F8 and F1.
As for NASH I think the language is very similar to previous comments with the difference that the proposed NASH phase 2b/3 is approved and the alternative financing mentioned in q1 is not addressed.
Below some comments about NASH during q1 CC:
“Although this unplanned circumstance is unfortunate, we're still awaiting feedback from the FDA on our protocol amendment, and and will continue to refine our NASH development plan by working towards identifying an ideal partner, reviewing alternative financing that can take the program through its interim analysis, and determining that we have a competitive method of demonstration for when we commercialize the product.”
SPCEO1 wrote: This is the small print Forward Looking Info (FLI) from the June corporate presentation:
Certain assumptions made in preparing the FLI include, but are not limited to, the following:
•
•(1) Global trade and supply issues will have limited adverse effects on our activities and
business plan;
•
•(2) sales of EGRIFTA SV ® and Trogarzo ® will continue to grow in the United States;
•
•(3) the known safety and efficacy profile of EGRIFTA SV ® and Trogarzo ® will not change as a
result of their long term use;
•
•(4) the FDA will approve the sBLA related to the IV Push mode of administration of Trogarzo ®
•
•(5) the FDA will approve the F8 formulation of tesamorelin , once an sBLA has been filed;
•
•(6) we will succeed in developing a multi dose injection pen using the F8 formulation and
regulatory agencies will approve same;
•
•(7) no biosimilar version of EGRIFTA SV ® will be approved by the FDA;
•
•(8) we will be able to secure additional resources to initiate our Phase 3 clinical trial evaluating
tesamorelin for the treatment of NASH, including finding a partner
•
•(9) the totality of evidence and data resulting from the conduct of our planned Phase 2b/3
clinical trial evaluating tesamorelin for the treatment of NASH will demonstrate substantial
evidence of efficacy and will be highly persuasive to regulatory agencies in order to gain
approval;
•
•(10) we will obtain positive results from our Phase 1 clinical trial evaluating TH1902 for the
treatment of various cancers; and,
•
•(11) we will meet all of the timelines set forth in this presentation.
And this is the same thing from the July presentation:
Certain assumptions made in preparing the FLI include, but are not limited to, the following:
•
•(1) sales of EGRIFTA SV ® and Trogarzo ® will continue to grow;
•
•(2) the known safety and efficacy profile of EGRIFTA SV ® and Trogarzo ® will not change as a
result of their long term use;
•
•(3) we will meet all of the timelines set forth in this presentation and related thereto;
•
•(4) we will meet all of the terms and conditions of the credit facility agreement to be able to
draw down on each loan facility tranche available thereunder;
•
•(5) no biosimilar versions of EGRIFTA SV ® will be approved by the FDA;
•
•(6) we will be able to continue the recruitment of patients to conduct the Phase 1 clinical trial in
oncology;
•
•(7) we will obtain positive results from our Phase 1 clinical trial evaluating TH1902 for the
treatment of various cancers;
•
•(8) we will be able to s ecure additional resources to initiate our Phase 3 clinical trial evaluating
tesamorelin for the treatment of NASH, including finding a partner with resources and
capabilities;
•
•(9) the IV push mode of administration for Trogarzo ® will be approved by the FDA;
•
•(10) our 2022 business strategies will not change.
So, any reference to the F8 was dropped. Global trade and supply issues was dropped too. New loan info was added as was the risk of not being able to recruit patients for the phase 1b. Point 9 in the June presentation regarding NASH was also dropped which indicated they thought the evidence for NASH would be highly persusive to the FDA.
Also, the last point on the fourth and final slide in the NASH section was changed - the interest in non-dilutuve financing was removed. So, TH is no longer looking to finance NASH via any kind of financing other than from a partner. Since I really do not think this is going to happen due to patent concerns (I suspect they are not strong enough and not long enough to suit most potential partners), NASH is a real long shot at this point. If TH sees good cancer data in phase 1a and moves into phase 2, I suspect they will drop any mention of NASH at that time as it really seems less realistic as each day passes and these changes in the presentation highlight that.
Iam a little concerned about the references to the F8 formulation being dropped as we would all like to see that developed and used for lipodystrophy but perhaps it does not make economic sense if it is not going to be used for NASH too?