You should have asked WHEN are they gonna release phase 2 results, which ended ealrly last year
f*** Allergan. Serial Dropping Of Future Treatments.
- Thread starter jamesbooker1975
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You should have asked WHEN are they gonna release phase 2 results, which ended ealrly last year
Well truth. You can write to them as well. And you said yourself that it is about to happen years after end of phase II, didn't you?
I hope you are wrong. Or at least Fevi will do the job.
Yup standard for these big company is 1 year from the end of the trial. The study ended in May 22, 2018, so, we have to wait until May 22, 2019 to see the result. If there is notthing new after May 22, 2019, then, we can safely concluded that Seti and PGD2 concept are DEAD.
Where did you get info that it bare minimum? I would guess that even if seti works, 2g is huge dosage, and twice a day is annoying, and not really practical if you compere it with poison Propecia. However i still would use it with smile on my face. I was happy with finasteride hair results, but side effects were as bad as great were my hair results. But if Fevi would be first, i would use it. Same thing just stronger and one pill.
I don't know. Hopefully it is on the way, yet i still hit fevi when it come out.
Right now i am experimenting with ceritizine 10mg/day, and order derma roller.
Allergan is not going to release news of major updates to their pipeline to some random person over email since pipeline cancellations have a major impact on earnings projections and estimated R&D expenditure -- and, therefore, share price. Changes to the pipeline will likely be released during a quarterly earnings report and, if Seti is cancelled, they will wait until the last possible quarter for it still to not be "overly-suspicious" that they haven't scheduled phase 3 trials before breaking the news. In short: please don't bother the PR grunts responding to public emails and phone calls since you aren't going to get any information that we don't already know unless you happen to be a financial analyst asking a question on an earnings call. If they cancel Seti or announce trial results, it will be in an easily-searchable press release online -- and likely posted here within minutes.
Also, Pharma companies are not required to publish the results of failed trials and many choose not to since it can give their competitors pursing similar compounds an advantage (ex: Novartis would likely gain valuable information from Seti's phase 2 trial results to more accurately judge whether or not to pursue Fevi's approval for this indication in the future).
One more thing to note: It may not be Allergan being 'overly-picky' that caused the alleged cancellation of Seti. It may in fact be the FDA's standards. I used to do financial analysis of pharmaceutical companies (including Allergan itself) and saw this all the time. New drugs for medical conditions that have existing treatments have a high bar set by the FDA: They have to prove themselves EITHER more efficacious than current treatments OR less risky (less side effects). Since the FDA doesn't currently recognize that Finasteride is nearly as "risky" as many on this forum believe it to be (not only do they not recognize the existence of permanent side effects, they also hold that the prevalence of temporary side effects is the same fraction of a percentile demonstrated in the approval study), Seti basically had to prove itself to be noticeably more effective or risk not meeting the FDA's standards during final review. If the results of Phase 2 were only equivalent to Finasteride, Allergan may have deemed it too much of a risk to proceed with Phase 3 since the FDA would likely not find any benefit in approving a drug that was "equally safe and effective" to the current best drug but with 20+ years less demonstrated use in the field. Even if Allergan decided to take the approval risk in this scenario, they would then be faced with the steep uphill battle of having to advertise and do doctor education for an expensive brand-name drug without legally being able to say that it was 1) safer or 2) more effective than the cheaper generic alternative of Finasteride.
So, trust me, no company is so picky that they consider discontinuing development of a drug just because it isn’t a “magic bullet” or “100% cure” — if companies did this, they would go bankrupt. If they thought it had a decent chance of approval despite not being a total cure and would just BREAK EVEN on development/advertising costs, they would not hesitate to go forward. Cancellation of development of a drug means that they see difficulty in either approval odds or in making their money back. I’ve seen more times than I can count companies moving forward with borderline ineffective stuff just because they thought it could slip by approval and make money. The equation is purely financial.
EDIT: Here is the relevant section from the FDA's website: https://www.fda.gov/drugs/developmentapprovalprocess/default.htm
"Analysis of the target condition and available treatments—FDA reviewers analyze the condition or illness for which the drug is intended and evaluate the current treatment landscape, which provide the context for weighing the drug’s risks and benefits."
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Interesting read!
Since finasteride is not fda approved for females, I wonder why pharmaceutical companies don’t try recruiting female participants instead.. it would be a lot easier for them to succeed since finasteride wont be used as a benchmark.
What about things like Samumed? Does the fact that it works on a different pathway to finastrride mean fonasteride won’t be used as a benchmark?
I don't want to spoil the party, but Allergan had their Q4 2018 Earnings Conference on January 29th and it really doesn't look good for Setipiprant. It isn't even mentioned once in their whole presentation. They also showed their new pipeline and there was also no sign of Setipiprant. It might still be too early to draw conclusions, as the trial was only finished last May and Allergan once emailed another user that they wouldn't publish any results before March 2019. But still I think it's a bit weird that there is no mention of it whatsoever. Especially since they mentioned it in their quarterly updates until Q2 2018.
Please don't get me wrong, I really wished for Seti to work, but all of it doesn't look very promising. I still hope they publish their trial results, so at least we can draw conclusions if the PGD2 hypothesis works or not, and therefore can switch to Fevipiprant in the future.
That's the presentation:
https://www.allergan.com/news/assets/q4-2018-earnings-deck_final
But let's still hope fore the best in March-May this year. They might surprise us all
Please don't get me wrong, I really wished for Seti to work, but all of it doesn't look very promising. I still hope they publish their trial results, so at least we can draw conclusions if the PGD2 hypothesis works or not, and therefore can switch to Fevipiprant in the future.
That's the presentation:
https://www.allergan.com/news/assets/q4-2018-earnings-deck_final
But let's still hope fore the best in March-May this year. They might surprise us all
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My friend, if setipiprant doesn’t work and the results are insignificant with a large dose, then fevipiprant won’t work either. It would mean the mechanics behind it are flawed and don’t correlate strongly w alopecia. Don’t get me wrong, I would love an alternative to finasteride & popping a pill once or twice day requires much less dedication than going to get an injection or applying a topical daily.
My hope is that they had decent results. But unfortunately they still might not be going to market it. Setipiprant also showed results in the asthma trials, but still was not good enough to start a phase 3, while Fevipiprant, which also targets exactly the same crth2 receptors and also didn't have significant side effects, has shown better and significant results and is considered a game changer is asthma therapy. Imo this shows that Setipiprant is just too weak as drug. So in the end, even if Setipiprant would do a good job for only maintaining one's hair, it would still have 2 strong drugs as competitors. On the one hand Finasteride, which is proven to be effective for maintainace and even some regrowth, and on the other hand Fevipiprant, which is proven to be a stronger crth2-blocker.
But all in all this doesn't mean that the pgd2 hypothesis is wrong per se. I mean there have actually been users on multiple forums who had results (mostly maintainance) with Setipiprant orally or topically.
I just think it's very hard to market a drug or even get FDA approval for a drug, that is weaker than two direct competitors that are already approved and available.
Edit: I just realised @hairq actually had the same thought a few post before this. Sorry if this post is too repetitive
But all in all this doesn't mean that the pgd2 hypothesis is wrong per se. I mean there have actually been users on multiple forums who had results (mostly maintainance) with Setipiprant orally or topically.
I just think it's very hard to market a drug or even get FDA approval for a drug, that is weaker than two direct competitors that are already approved and available.
Edit: I just realised @hairq actually had the same thought a few post before this. Sorry if this post is too repetitive
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@Dhldan but it does work. There are people who were using it in private forums and they have positive impact on hairs. Seti was made for Asthma at first... but it was too week, but it had impact on hairs. So that's why there are resarch on hair impact
However even if this work it is going to hard sell it since business and pharma industry believe that finasteride give only 2% of users sides. Even if Seti would have same results ratio, it would have disadvantage against finasteride simply because dosage thing.
However even if this work it is going to hard sell it since business and pharma industry believe that finasteride give only 2% of users sides. Even if Seti would have same results ratio, it would have disadvantage against finasteride simply because dosage thing.
All anecdotal, if anecdotal studies were accurate then zix, castor oil, biotin and a number of other treatments/natural supplements would be effective in treating male pattern baldness.
If somehow fevi works then I wouldn’t c it as a disadvantage to finasteride as it doesnt mess w hormones and from what I heard only causes sleep apnea for the first few weeks.
(I hardly sleep anyways 4-6 hrs a night).
If anything I’d add it to my finasteride regiment.
As for dosage-
Idm taking 2 grams at all, it’s just like taking supplements anyways.
Yeah seti needs to be used at the correct dose.. the private forum his doing a huge group buy with lower prices per 25g now ($220). Chinese New Year is going to hinder when we will get it but message me if anyone seriously wants in.. I’m buying around 100-200 grams so I can destroy my scalp itch til summer