1) Preclinical (animal) testing. 2) An investigational new drug application (IND) outlines what the sponsor of a new drug proposes for human testing in clinical trials. 3) Phase 1 studies (typically involve 20 to 80 people). 4) Phase 2 studies (typically involve a few dozen to about 300 people). 5) Phase 3 studies (typically involve several hundred to about 3,000 people). 6)The pre-NDA period, just before a new drug application (NDA) is submitted. A common time for the FDA and drug sponsors to meet. 7) Submission of an NDA is the formal step asking the FDA to consider a drug for marketing approval. 8) After an NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed. 9) If the FDA files the NDA, an FDA review team is assigned to evaluate the sponsor's research on the drug's safety and effectiveness. 10) The FDA reviews information that goes on a drug's professional labeling (information on how to use the drug). 11) The FDA inspects the facilities where the drug will be manufactured as part of the approval process. 12) FDA reviewers will approve the application or issue a complete response letter.
A: The 1992 Prescription Drug User Fee Act (PDUFA) established a two-tiered system – Standard Review and Priority Review.
Standard Review is applied to a drug that offers at most, only minor improvement over existing marketed therapies. The 2002 amendments to PDUFA set a 10 month goal for a standard review.
Priority Review designation is given to drugs that offer major advances in treatment, or provide a treatment where none existed. The goal for completing a Priority Review is six months.
Maintain BUY and SOP-derived MYR6.37 TP, 22% upside, 4% yield.
Genting's 20.3%-owned pharmaceutical company TauRx has completed the Phase 3 clinical trial (LUCIDITY) of its Alzheimer's treatment, HMTM, and is moving towards regulatory submission.
We are positive on this development, as it marks a step forward for TauRx to potentially bring HMTM to the market, providing greater visibility to its path to profitability.
In the late 1980s, Professor Claude Wischik and his teacher at Cambridge Professor Sir Martin Roth already knew Tau is the driver of AD and not Amyloid. They have a mini brain bank in their Cambridge lab, abt 300 donated brains from deceased patients. Slice up the brain cross section and study it under microscope. All the results clearly show that brains with tau tangles were demented as per the health record of the deceased, brains without tau tangles were not demented. This is against the theory of the most widely accepted Amyloid hypothesis. Amyloid deposits are inconclusive whether the patient is demented or not. There are patients with brain full of amyloid but not demented, there are patients with no amyloid in their brain but they are demented.
Late 1990s, Professor Claude discovered a compound called methylene blue is able to dissolve tau tangles very effectively. From late 1990s to 2022, it took us abt 25 years to prove the effectiveness of this drug compound in a phase 3 trial. A quarter century!
These days we don't have to slice up donated brains and look under microscope. The huge advancement in brain PET scan technology on life patients clearly concludes that spreading of Tau tangles is the main culprit and driver of AD. In the face of these hard facts and truth, we still have the vast majority of the clinical trials devoting to targeting amyloid deposits, still in denial that Tau is the main culprit of AD.
We are the pioneer of Tau based treatments in the AD field and TauRx is truly light years ahead of all the competitors. I will expect naysayers from the amyloid hypothesis camp to continue to discredit us. They will also come up with something like "targeting tau looks ok, but targeting both tau and amyloid will work even better". Of course the amyloid camp professors will try to save their livelihood even with hard facts that show their decades of neurology studies / expertise are total rubbish and won't work. If amyloid theory is correct, they would have come out with a drug that can work long ago. Politics at science is delaying the advancement of AD research, hence we haven't got a drug that can work...... until yesterday's phase 3 clinical trial result.
@AngTayKor, yr explanation makes sense. There’s no right or wrong basis when determining d sampling population size. Wats really more important is d statistical data collected and d methodology used yields consistent outcomes and r able to explain any outlier occurrence. Of course, its outcomes cud b even stronger and more convincing with a much larger sampling population size. But then, costs cud b any issue as well in d long run. At times, hving too large a sampling population size cud b less accurate due to more variables to manage for accuracy of study.
YES TWYNSTAR TAURX IS A MAJOR ADVANCEMENT AGAINST ALZHEIMER'S AND PRIORITY REVIEWS TAKE 6 MONTHS ! HIP HOORAY THE US HAS ALSO DEMONSTRATED A PROPENSITY TO FAST TRACK DRUGS LIKE THE GROUND BREAKING MRNA VACCINES IN SHORT JUST HOOT9EEE
YES SENGGOR1011 SOON TO BE LAUGHINGGOR2022 RHB MAINTAIN THEIR TP BUT WHEN TAURX RECEIVES APPROVAL...IMAGINE WHAT THE SHARE PRICE WILL BE...AMONGST THE STAR SPANGLED BANNER WHERE ANGELS TREAD
The conference on 9 Jun in London w b a very good and important platform to present findings of studies and to get buy-ins for regulatory approval and full adoption. All d very best for d advancement of mankind.
Bro Rr88, Are you confident in what you say below? Why you have the conviction to say that…? Please explain? Because you never explain. Thanks for your explanation in advance.
——-
Posted by rr88 > Jun 2, 2022 2:52 PM | Report Abuse
Dont get fuked by the same conman twice at the same place, on the same road....stay away.. TP 4.50
wannabe boss of genting forum 2Invest2…. cakap manyak ---------------------------------------------------
If Cha Cha aunty has been using the same I.D. stocksafeplayer and didn't delete so many of her old posts, I estimate she would have made over 100,000 posts by now. Confirm i3 will crown her the boss of GentB forum. Anyone here knows why cha cha aunty likes to change her I.D? Is it her old I.D being monitored by some authorities?
If willing to take the risk, then steel stocks should be good as demand of steel will rocket once China fully opens up! But then again depends on China if they quietly remove the Zero Covid policy!
Bro Tobby, Another good idea. Thanks for your advice. I will look at your recommendations.
—-
Posted by Tobby > Jun 2, 2022 4:18 PM | Report Abuse
If willing to take the risk, then steel stocks should be good as demand of steel will rocket once China fully opens up! But then again depends on China if they quietly remove the Zero Covid policy!
Attended Zoom AGM of GENM this morning, staff cost more than $1500, minimum wage not an issue. GenM's borrowing mainly on bonds, which is main fixed, current raising interest rate is also not an issue. I guess same applied to Genting Bhd
At current price level, the risk / reward favours investment even without the drug outcome being favourable. Genting price will recover well past 6 mark when it’s core activities and markets pick up. If you then add the remote probability of the the drug being successful then any thing is possible. So the risk is worth taking for a significant uplift in price if the drug receives approval and is successful. To me reading the trial,results suggest that it is not totally unrealistic for the outcome to be positive.
Post a Comment
People who like this
New Topic
You should check in on some of those fields below.
Title
Category
Comment
Confirmation
Click Confirm to delete this Forum Thread and all the associated comments.
This book is the result of the author's many years of experience and observation throughout his 26 years in the stockbroking industry. It was written for general public to learn to invest based on facts and not on fantasies or hearsay....
shavemyfurm
534 posts
Posted by shavemyfurm > 2022-06-02 13:01 | Report Abuse
Nice pick up