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And how many CRL's for the ANDA's Elite has already submitted...several of which have already been approved BTW?
Okay, is there a link where any pharma has provided the original copy of a CRL that they received?
What a load of BS. Nasrat hid nothing about the SequestOx Tmax issue. When Elite met with the FDA in 2014 they indicated the issue could be remedied with labeling instructions.
https://s3.amazonaws.com/sec.irpass.cc/2258/0001144204-16-113802.pdf
"The result of the BE study for SequestOx as comparing SequestOx to the brand were bioequivalent for the area under the curve, Cmax and Tmax. Comparing the profile of SequestOx under fasted versus fed conditions indicated that a fatty meal slows down the Tmax, not the Cmax or AUC but the Tmax. Historically this has been a labeling issue whereby the product is labeled and the doctor and the pharmacist will instruct the patients to take the product an hour before a meal or two hours after a meal.
"In our meeting with the FDA in November of 2014, Dr. Hertz requested three extra studies:an efficacy study (a Bunionectomy), an anti-abuse study and a BE study - sorry, it was a withdrawal study and a BE study. We indicated that we know that there is a food effect on our product so why are we doing another BE study for fed? FDA clearly stated that this is not a pass or fail, it’s a BE for labeling issue."
So, all of the requested tests (by Dr. Hertz) were completed and the NDA was filed. Then, having received the application, the FDA changed their mind and decided labeling could not be used and issued a CRL. Doesn't seem fair but it's a fact of life when dealing with the FDA and their habit of providing guidance then changing their mind.
I believe you know why if it's the alcohol dump test you are referring to.
There were no negative incidents during the SequestOx PIII trial. BTW all trial participants were permitted to eat whatever they wanted; i.e. fatty or low/non-fat meals. I believe that is what Chasing is saying.
Transcript for August 12, 2019 Conference Call:
https://seekingalpha.com/article/4284978-elite-pharmaceuticals-inc-eltp-ceo-nasrat-hakim-q1-2020-results-earnings-call-transcript?part=single
What. . .less than a million in cash now? I must be reading the last Q all wrong.
Actually the nonsense is denying there was a shortage of Adderall IR and its generics. This shortage, which occurred earlier this year, is well documented.
Yes, but there is a missing message from the board thread alleging Nasrat was not able to "forcast" the Q1 rev's. Glad I could clear up this hilarious nonsense.
Nah. . .the nonsensical allegation was that Nasrat was not able to "forecast" the Q1 results which, of course, is BS.
The Q1 rev's will double from approx. 1.4 mil to 2.8 mil as indicated in the last CC and the soon to be released financials. I am not sure how the PPS will react to this doubling event but it is laughable nonsense to suggest Nasrat did not know during the CC (on June 24) what the Q1 rev results would be a week before Q1 ended. Yes, Nasrat was confident in declaring Q1 rev's because he knew how much was on the books.
Absolutely. . .1.4 to 2.8 mil in Q1 rev's. I agree. . .that is stupendous. Yippee!!!
Yep. . .still looking forward to that 1.4 to 2.8 mil double in rev's. It's already in the books. Yippee!!!
Absolutely. . .a double from 1.4 to 2.8 mil. Looking forward to it. Yippee!!!
Yep. . .Q1 rev's in books. . .1.4 mil to 2.8 mil. I agree; case closed.
Hysterically funny. The revenue statement was made when Q1 was two weeks from completion. I would think Elite would have known by then how much revenue was on the books when the guidance was given. So yes the revenue will double and not the laughable nonsense alleging it will decrease.
Yes and it is still disingenuous and nonsense to state that "earnings" (revenues) will decrease this coming quarter when revenues will be doubling.
Yes you are right. I was responding to the bullshit about "lower earnings".
And yes, it is revenues that the guidance is talking about. LMAO
Well. . .that's a load of bullshit. The 2019 Q4 earnings were approx. 1.4 mil. Guidance provided during the last CC indicated the earnings for 2020 Q1 would be double or approx. 2.8 mil. LMAO
The Q1's for the previous three years were filed on August 9 and, if the trend continues, this coming Q1 will be filed next week on Friday, August 9. The CC will probably occur on the following Monday.
no link = BS
Sungen is a privately owned company but I was told it trades overseas. Should be easy to look up their financials which are posted over
there. . .right? LMAO
n2k. . .yes, I had a good laugh when I read that. It was pure unsubstantiated crapola. GLTY
I am willing to wait for the approval of ANDA #2 and subsequent appreciation in share price. I would love to revisit this thread when that happens.
Sorry. . .but that is more conjectural nonsense.
So when Nasrat's J series shares are converted to common stock and the Elite ship sinks (hypothetically). Wouldn't his shares go down with him like the rest of the shareholders? Nasrat is the largest shareholder in Elite (he owns 20+%). He has the most to lose should something happen to Elite. Please tell me how he would benefit from a disastrous event when the rest of the shareholders are drowning.
More nonsense. I am not buying it. ANDA #1 approved/launched with ANDA #2 on deck for approval in December. And yes, the next CC will shed more light on Sungen/Elite alliance in a favorable manner. Let's wait and see shall we?
Nah. . .that's bullshit
Conjectural nonsense. Elite/Sungen ANDA #1 was approved and launched in May with ANDA #2 scheduled for approval in December and now I am supposed to believe the deal with Sungen is invalidated? LMAO
The conversion of Series J shares to common stock is locked in at .1521 cents a share. Now if you are talking about stock dividends which are tied to the J's or the sale or grant of shares below the conversion price (shares not be part of the core number of J's) then yes there could be a deviation from the stated .1521 conversion price.
And your reference to the possible conversion of J's at .07 cents to result in 343,348,571 shares won't happen because, as I previously stated, the J's are locked in. Any related transactions to the issued core number of 24.0344 series J could involve a deviation of the conversion price such as (from the 10K - page 79):
"Subject to certain exceptions, the Conversion Price is subject to adjustment for any issuances or deemed issuances of common stock or
common stock equivalents at an effective price below the then Conversion Price. The Conversion price also is adjustable upon the happening of certain customary events such as stock dividends and splits, pro rata distributions and fundamental transactions."
https://s3.amazonaws.com/sec.irpass.cc/2258/0001213900-19-011224.pdf
Summary: There is no ratchets associated with the core Series J shares.
Newguy. . .I like your sense of humour. GLTY
Ha. . .good one. I agree, good news is a comin'
What a load of bullshit. LMAO
Thanks JJ. The approval of Adderall XR will be a milestone event for Elite in that it will be the largest potential revenue producing ANDA ever filed by Elite (and Sungen). I am anxiously awaiting this approval and launch. It will be a great day for all shareholders.
I am pretty sure he will not "dance around it". If there is cause for delay he will say so in the CC. That's my opinion.
I strongly disagree with this misinformation. Fact is the CEO stated in the last CC he expected approval for the Sungen CNS product #2 in the calendar Q2 period (April - June). June is not over yet. Elite is awaiting approval from the FDA. There is nothing more Elite can do now other than wait.
Newguy. . .interesting info. I did not know that.
Let's lay this to rest once and for all. It's BS to allege Sungen trades at all. It is a privately held company. . .no trading occurs on any exzchange.
Show me a public company does NOT have an "Investors" tab on their website.
Waiting. . .
And yet Sungen knowingly posted the information on their website that they are a privately held entity. Have you noticed that the websites of publicly traded companies have an "Investors" section and yet Sungen has no such thing on their's? That's because they are a private enterprise.