RE:RE:No value for Pipelineqwerty22 wrote:
I think we have to wait the next few months for the mud to clear.
I wish I had a nickel for everytime that has been said in the past 5 years ...
-LT
qwerty22 wrote: If we go with the worst case scenario and they don't do the trial with the EMA, I don't know that data generated for the FDA can't be used for an EMA approval. All we are talking about is the present moment in time. The EMA doesn't like the present data set, they may like the future dataset once they have the Ph3 data.
Here's my take on a possible scenario. The EMA muddies the situation short term because they want more Ph2 data for whatever reasons. The company avoided submission with the EMA to avoid rejection which they would need to announce. Next six months all this comes to light. The FDA are essentially going with some form of Ph3 the company initiates that. Maybe they also initiate a parallel smaller Ph2 study in EU to answer some of the EMA's questions. Together both studies allow approval in both regions. The muddying in this scenario is really only muddying the short term perceptions of the program, essentially validating the RBC guys sceptical position (and therefore impacting raising cash). It might not really be impacting the overall potential final value of this program. Look as I keep saying the lack of robust biopsy data is real, that remains an uncertainty whether they have both regulators on board or not so potentially it doesn't change much for me. This muddy situation they find themselves in is just a reflection of the odd dataset they have but that data set is still valid (if "odd") and you can still draw conclusions from it.
You could think of this as deception by the company. You could also think they are in a tricky situation and they are just trying to navigate the best route for the company. They have clearly left out any talk of the EMA's position in recent documents, that should raise issues for people buying this financing. They've clearly said the FDA talks are ongoing so exactly where that lands is unknown. So for anybody investing there is still a lot of uncertainty about this short term part of the process and its long term impacts.
Maybe we'll end up being less harsh on the RBC guy, maybe the right thing to do is wait for this clearly complex regulatory process to complete and assess the situation based on exactly what THTX has. Maybe that's really all the RBC guy is doing and that might mean we eventually get something substantial from him once all the details are clear.
I'm still trying to trust the management so I think we will have a Ph3 of some type with the FDA and maybe there'll be some type of addon to appease the EMA come approval, hopefully that doesn't impact timelines. I think we have to wait the next few months for the mud to clear. I'm hoping it's just short term uncertainty that doesn't impact the long term potential. They have laid out all the best features of the situation in order to raise cash, the clear ongoing short term uncertainties are reflected in the price they had to pay for that cash. Why they didn't wait might be more based on external factors than some serious internal hidden flaw. I'm fine with the transparency around the data supporting the program, we do know it warts and all.
Summary without knowing any of the details. As thing stand :-
The FDA are validating the companies position.
The EMA are validating the RBC guys position.
The cash is being raised in that muddy situation and priced accordingly.
The company are still navigating the best possible outcome with both regulators.
Having delivered a Ph3 with the FDA I'm going to back them to deliver a solution that potentially has both regulators on board come approval time. This is a complex situation they are in I'll back them to do the best they can.
The financing will never stop looking ugly
That's my final take on the situation until I change my mind.
(hopeful that summary is clearer than the garbled stuff before it)
SPCEO1 wrote: With the cash adjusted market cap at less than 3x revenues, it is pretty clear the market is giving no value to either NASH or cancer. Cancer is understandable since we have no human test results yet. On NASH, if you exclude Europe, then my suggestion that TH's discount to MDGL and NGM' valuation of 40% should probably rise to 70% since half the NASH market could be unavailable to TH. Even assuming that, THTX should still probably sell at around $7-$8 on a conservative basis ($2 for the legacy drugs and $5.50 for the US NASH business). You could also bump that 70% discount lower to 60 or 65% to reflect the better profitability of the US NASH market versus Europe.