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It's spelled out in the script, and I was amazed when I heard him say it in the movie.
And "Limitless" was released in 2011.
In "Limitless" Bradley Cooper's character mentions eicosapentaenoic acid (EPA) as a drug his aunt should be taking to treat a tumor.
fishhunter - great call on the timing for CNAT spiking.
Would you share what indicator you used to know it was ready to move up?
Thanks.
I appreciate your information and I believe it's correct; I'm just looking for clarification on what Equitiesduke is posting on the same subject.
Obviously I don't believe the market will be paying me 10 to 1 for buying FTRPR today.
When it was issued in 2015, the FTRPR shares were convertible at any time at the holder's option to 17 and a fraction shares of FTR common stock. Are you saying I can buy 1000 shares of FTRPR for approximately $25,000 and immediately convert them to 17,000 shares of FTR worth approximately $250,000 at today's price?
Quite a deal if correct.
NVS/AGN/CNAT - Dew, I would be interested in your ideas on why CNAT's drug is mentioned in the NVS PR announcing the clinical trial agreement with AGN, but excluded from their combo trial.
I certainly hope it is approved, for financial and personal reasons! And I agree with TGTX dropping the SPA on the GENUINE trial - the slow enrollment and PFS endpoint would have required far too long to get the final results.
I just don't think approval is anywhere near certain. The FDA has a history of changing the rules without warning - there is no guarantee they will accept an ORR endpoint now even though they used it for past approvals in the same indication.
Regarding the SPA(s):
I heard the TGTX CEO (Mike Weiss) mention "the SPA" during the Oppenheimer conference 3/21/17. I emailed TGTX's IR Dept. to request clarification, and the VP of Investor Relations (Jenna A. Bosco) replied within an hour:
Thank you for the note, XXXXXXXX.
I just re-listened to the time point in question (13:50) and at that moment Mike
Weiss is referring to the SPA we currently have in place for our UNITY-CLL
trial, which is currently a 4 arm study evaluating:
1) the combination of TG-1101 plus TGR-1202 vs.
2) Gazyva Chlorambucil vs.
3) TG-1101 Single Agent vs.
4) TGR-1202 Single Agent
The GENUINE trial, evaluating TG-1101 plus ibrutinib versus ibrutinib alone, was
amended in October of 2016, and as so, the revised GENUINE trial was no longer
being conducted pursuant to an SPA.
Please let me know if you have any additional questions.
Best,
Jenna
Jenna A. Bosco
Vice President, Investor Relations
TG Therapeutics, Inc.
2 Gansevoort Street, 9th Floor
New York, NY 10014
Office: 212.554.4351
Fax: 212.554.4531
Email: jb@tgtxinc.com
It is possible. There does not have to be an SPA for approval. TGTX is arguing that Imbruvica, Zydelig and Venclexta were all approved on response data from single-arm studies and no SPA, so a positive benefit in Genuine under the same terms ought to achieve the same result.
If an amended and FDA approved SPA currently exists, on what terms?
TGTX is being sued by several law firms. I know these law firms are ambulance chasers, but they at least need to state a reason to file a lawsuit. Their stated reason is because the SPA was invalidated.
To me, that means they no longer have an SPA
TGTX amended the GENUINE trial to evaluate only the overall response rate of patients receiving the drug combination, rather than measuring how long patients live with the disease following treatment.
Also, they reduced the number of patients from 200 to 120. Their PR said the FDA has agreed that Overall Response Rate (ORR) data from the revised GENUINE study can be used to request a pre-BLA (Biologics License Application) meeting. Using this data to request a pre-BLA meeting is a far cry from the FDA approving a modified SPA. This meeting has not even taken place yet, and there is no guarantee the ORR data with fewer patients will be accepted as adequate for a possible approval.
If you can show me where the FDA agreed to amend the SPA to accept ORR and fewer patients after TGTX made these modifications, I'd like to see that.
Do you have a link to that information, or can you copy and post an "ok" from the FDA which approved a modified SPA?
I hope you're right!
TGTX has not mentioned the "Fast Track" designation for MS as far as I know, and I don't know if it's even available for that indication.
The real question for TGTX's valuation is this - Will the FDA approve their cancer trials after TGTX arbitrarily scrapped the SPA, or will they make TGTX run another lengthy and costly trial before approval?
They did not give any details on why there would be cost savings for them compared to current treatments; they only said that they could charge half to disrupt the current market and still make a nice profit. No matter how much price competition occurs, TGTX said they should have a big advantage with a one-hour infusion time for TG-1101 versus four hours for other treatments.
During the presentation, TGTX compared TG-1101 to ocrelizumab (Ocrevus), which is currently in use for b-cell depletion in MS. TGTX did not claim a safety advantage or an efficacy advantage over ocrelizumab. They said their advantages will be convenience and cost if the drug is approved.
Adverse events in CAR-T cancer trials are not relevant to the MS trial.
TGTX implied all the B-cell depleting drugs work pretty much the same. They may have an advantage in fewer adverse reactions at the infusion site.
TGTX said their main advantages are speed of infusion and lower cost (they said they can see cutting the cost from $80,000 to $40,000). They expect to take a large share of the existing market with those advantages, if they get FDA approval.
Dew - Any thoughts on why Revance has gone from $16 to $19 and climbing the past three trading days?
Dew -
1. Why hasn't ABBV been able to sell more of their HCV drug, relative to GILD's sales?
2. Do you believe the newly approved once-per-day pill will make any difference in sales?
3. Do you believe ABBV will be able to compete better with their next-gen drug?
Thanks Dew.
At the Leerink presentation 2/10/16 Enanta said other than treatments for RAV's they are done with HCV development. The conversation begins about the 11:00 minute mark. They have been concentrating more and more on HBV, NASH, etc. for future drug candidates.
Dew - other than the hedge fund problem you identified, I am impressed by TGTX's reported results. To my untrained eye, the efficacy and reduced AE's of their drugs make them potentially superior to the current SOC.
Do you have an opinion on their data so far?
Does anyone have a guess why ENTA has gone from 30 after the downgrades in January back to near all-time highs in the low 50's in July? I think V-Pak sales have been disappointing and I haven't seen any upgrades.
Is it all due to buy-out speculation?
Perhaps the Barclays analyst was a student in the same math class with the Credit Suisse analyst who in mid-February this year predicted V-Pak sales of $800 million in 2016, and declining every year after.
I wonder what those analyst jobs pay?
Some investors might believe the sales trajectory of V-Pak will mimic Incivek and Victrelis. But why would a professional analyst who is leading a team of other analysts believe that? And what will he say if he is wrong by 300% - "my bad"?
I think one problem with ENTA's stock price is that the Credit Suisse analyst thinks ABBV is only going to sell $800 million dollars worth of V-Paks in 2016, and less every year after.
Can anyone contact Ravi Mehrotra to ask why he thinks sales will fall off a cliff next year, when ABBV has projected sales of $250 million per month by December 2015?
Not to argue, but is Invitae pronounced In - vee - tee -a?
Exxon before the Mobil merger?
How much profit will Amphastar make on A-enox per year?
Would it make sense for Momenta to pay them not to launch?