SPCEO1 wrote: I am not able to keep up in a timely manner with all that is going on here at moment, so i am just catching up on some of the recent posts. I am not an expert on patents or drug manufacturing but I hage asked the company about these issues in the past in regards to Egrifta and the feedback I got was that Egrfita's patent situation is one that could have already come under attack if the generics were interested and one of the reasons why they apparently have shown no interest so far is because of the difficulty in manufacturing Egrifta. The lytholization process (?), I beleive is the big stumbling block and is what led to the drug being out of stock for some months in the past.
On a related note, if NASH is a big deal, then they are going to need more Egrifta in stock. Could this be one reason why F4 is been delayed as they intend to be ready to roll out F4 for NASH as part of its introduction to the market? I am not sure how long the FDA might take to add NASH to the Lipo label, but that could be part of the reason - they need more time to increase the stocks of the drug. Or maybe they think that just the off label use of the drug will require more inventory.
Also, I am sure they are really going to want to have more than one production facility for F4 if NASH becomes a reality. Like, really, really sure! So, I am not sure what that involves from a time and cost perspective but I have to beleive we are going to be hearing about that shortly after the NASH results are out, they have spoken to the FDA about the path foreward if those results are good and they have figured out exactly what they plan to do.
Christian hit on 3 of my six scenarios on the conference call. He did not waste any time on the first two "easy" scenarios (patients with lipo and NASH taking it more for NASH while being prescribed it for lipo and off label usage by wealthy NASH patients in the US). He went straight for my two "likely" scenarios (3 and 4) where they get the FDA to add it to the lipo label and for approval in Europe, while also throwing in my sixth scenario - the really, really big scenario - of going after the general non-HIV NASH market. If they just go after 3 and 4 they are going to need more production facilities, but 4 will take some time to accomplish so there is not as big a rush for that.
reading over the transcript again of the conference call, I got the sense that Christian believes the FDA might be willing to add NASH to the lipo label on the strength of the current, effectively phase II, trial data (assuming it is strong) due to the long term demonstrated safety of the drug. But this investigator led trial (rather than company led) is not the normfor such things. They may need to do another small phase II to get the FDA to add it to the label. Obviously, to get approval in Europe in HIV NASH and to serve the general NASH population, they will need to do at least one phase III trial. I suppose an open question is if they are able to dispense with doing a phase III HIV NASH trial and are instead allowed to go straight to a non-HIV NASH trial for Europe. There are a lot of possible roads they could take so the discussions with the FDA and the EMA are going to be very important in determining timelines to commercialization.
Because it was an investigator led trial, I believe there was no FDA involvement in how the trial was set up. Therefore, there is a chance the FDA says, "well that is certainly intersting data you have there but what we are really interested in is X, so go back and redo the trial to find out about X."
I don't know what the future for Egrifta exactly will be but it is increasingly looking like this drug has a very meaningful future. And as someone here pointed out earlier, because its gross margin is roughly twice that of Trogarzo's, one new dollar of Egirifta sales is equal to two new dollars of Trogarzo sales in terms of bottom line impact. So, if they pick up an additional $100 million in Egrifta sales as a result of NASH, that is roughly the same as $200 million in additional Trogarzo sales.
Also, the move to reporting in US dollars is about as strong a hint that a NASDAQ listing is forthcoming as you can probably get. Which means it is likely also about as strong a hint as you can get that they think they have something with NASH. I could easily see this progression coming up over the next few months - first the NASH results are released, second they speak with the FDA and EMA and find out what is the most acceptable path forward, third they need more money to pursue a large phase III, fourth they raise the money by listing on NASDAQ to great fanfare. Also, if you read the transcript Luc had a half sentence in there where he seemed to say something about a NASH conference but he may have been referring to having an Investor Day like they did with Trogarzo. Those who were around at that time know that the stock took off after the Trogarzo Investor Day as the market finally woke up to what we had been talking about on this board for quite a long time.
Alternatively, they could pursue a partnership for Egrifta in NASH or sell the entire company if the data is so good it realistically opens up the general NASH market to them. I prefer going it alone, however, as that is where the most value would be created for us. No need to share that value with partners or acquisitors unless they want to seriously over pay for it!
jfm1330 wrote: Egrifta is easy to make. No problem for generic companies to copy it.
Thera has a second generation GRF called TH1173. It is still at the pre-clinical stage. They would need to do the whole development process to get it approve, from phase I to phase III.
IMB wrote:
What do you think? It appears that they have had discussions of some sort with Dr Grinspoon . If you had asked a year or so ago about egrifta and nash they would have said very little about it and would appear not to be of interest; but, now there seems to be great interest within the company. I ask; what about other variations of egrifta do they have that have not been patented. the other thing is how hard is it to make egrifta- the process. I wonder if the process is too hard for generics to commercialize the product. I do not know the answers to the question it is just food for thought.