RE:RE:RE:RE:RE:PRI suspect the argument the company would make to the FDA would be something like this:
1) Egrifta is safe, so there is very little risk in letting us go ahead into phase III. If it works for this as yet unmet need, great. If it doesn't, no harm done.
2.) if you don't let us move ahead directly to phase III, we may just drop the whole project as doing a phase II would put us too far behind the competition and the cost of the combined phase II and III trials may be more than we want to dedicate to this.
3.) We can imbed something like a phase II in the phase III by providing an interim analysis of the data. If you don't like what you see there, you can stop the trial at that point. But that is highly unlikely so why make us waste time with a phase II?
4.) If we got very interesting results with tougher to treat HIV livers, it makes sense we would do better with somewhat healthier non-HIV livers.
5.) Look at all of that Grinspoon genetic data - it is telling you important things are going on and no one else can show you such data.
6.) Our upstream approach also makes more sense and with the additional trial length (18 months) that stands a very good chance of showing up as a benefit for these NASH livers.
7.) So, we acknowledge we can't check all your normal boxes, but the weight of evidence is strong, we have the backign of well-known and respected advisors and the chance of there being any harm done is virtually zero.
Now, I did not mean to imply that TH would not pursue a phase II if the FDA mandated it. I was just making a point that without the phase III, they don't really need additional cash. They could wait until they get the phase I cancer results and raise cash after that if good or do partnerships to rasie money.
The question facing the board of directors, however, is when is the best risk-adjusted time to raise money. In a worst case scenario, Egrifta and Trogarzo sales slide progressively lower, the phase III is not approved and the phase I in cancer reveals a big issue with that program that means it doesn't move forward. Obviously, all of this is not likely to happen, but that is something a prudent board has to consider. Such a scenario would call for doing a capital raise sooner rather than later and despite the low share price. That is our risk right now - that a nervous nelly board opts for safety first and raises money at a low price in case everything goes wrong.
Ideally, they wait for the FDA to approve the phase III and raise money following the big jump in the share price that would certainly accompany that development. This is the most likely scenario. But if they raise money before the FDA rules on the phase III, that will tell us they are not as confident as they sounded when they announced the move into general NASH.
qwerty22 wrote: So you think there is no value in a Ph2 for Theratech?
Put aside what we want as investors, it would make no business sense to pursue a Ph2?
I thought the biggest stumbling block to that was the IP and a solution to that seems to exist. A Ph2 would still have some value.
SPCEO1 wrote: They will not head into the phase III in NASH without raising more cash, The big question is when and at what price (or how, parnterships in cancer or in NASH could raise the needed funds).
If they get turned down by the FDA on moving directly to phase III and then ditch the whole NASH program as a result, they likely do not need immediate cash as the cost of the cancer phase I is probably just $3-$5 million. Moreover, the one time impact of the rebates will disappear and hopefully, the pandemic will ease and then end, allowing sales efforts to resume as normal, which should bring them back to cash flow neutral or better if sales start to recover. Sales will also be helped on the margin by German and then other European Trogarzo sales over time as well as the hoped for positive impact of the new version of Egrifta causing patients to stay on the drug longer. On the negaitve side of the equation, Fostemsavir has launched in the US and that will likley limit Trogarzo's growth prospects in the US. I have not heard yet if Viiv has applied for Fostemsavir to be approved in Europe but that must not be too far behind.Even so, Trogarzo will have a little time to get a foothold in Europe and the hope is that once a patient is on Trogarzo, they will not come off of it since a MDR patient needs to keep access to as many working drugs as they can.
SABBOBCAT wrote: Q2 was a record high $17.2MM. If rebate and chargebacks were under reported in this quarter, or in all of 2020 and this is a correction then I am glad they got ahead of it. Revenues are averaging roughly $15.6MM in the first 3 quarters this year vs. an average of $15.8MM in 2019. Obviously it is disappointing not to see growth, but these numbers are hardly devastating in the face of the current environment. The cash burn is something they should address. we will have to wait for the financials to see how inventory is sitting, but I hope we can get back some of that cash if levels are higher than normal. $27MM is not much of a buffer heading into the start of two clinical trials. We really do need to see some traction in European sales soon.