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lol this dude..
should we wait for the rs? and play it safe?.. or play the spike comming up soon?..
Hell yeah..
So much that im stating the obvious** at 2 bucks or less lol
where were you Wednesday thru friday? last week.. Ahh stock dint spike, it did yesterday, time to short!! ill hope on the train too lol
Weeeeeeeee!!.. something is cooking and it ain't the turkey!!
we dint get a 30 min vid from clay from 20th,21st n 22nd..i wonder why? lol
3.16 first resistance!! if broken.. we flying high
I know right, it's funny how you reiterate "Let's see if the bulls can keep the momentum".. never ever heard you say "let's see if the bears can keep the stock down" lol.. by the way Clay you cannot make a 30 min video on a stock with .30 beta volatility with all them catalysts going on.. just saying homeboy!!
or sooner before that, anytime Rapture anytime next weeks will be interesting..
lets assume they sell for a 1.40 cent profits if it goes to 3$ thats a 44 mill on the bag i mean shit give me 44 mill i go on a multi family apartment shopping spree.. crazy money i dont think he wants a 44 mill these people want money power 100 mil and above is what i think they want in return
I finally Concur with you, the only WHAT IF I have is, per say these people know more than we do since their insiders but they dont hold the ultimate outcome from the FDA but WHAT IF they get rejected? they will know what to fix as they did from their last rejection.. but WHAT IF Agrx gets rejected they wouldnt take up a ton of stocks if they dint know something is cooking and cooking very well.. that's where im stading i just flipped it for a little $400 profit but im leaving my other stocks untouched
The Agile Therapeutics boss said the FDA has completed Corium’s facility pre-inspection~ Yours truly
Agile Therapeutics Inc (NASDAQ:AGRX) CEO Al Altomari said Monday that the women’s healthcare company was preparing for commercialization in the event that its lead product candidate, Twirla, an investigational prescription contraceptive is approved.
In a statement accompanying the Princeton, New Jersey-based women’s healthcare company’s latest numbers, Altomari said: “The third quarter of 2019 was another productive quarter for the company. We raised much needed cash to fund our business and allow us to reactivate Corium to prepare for commercialization in the event that Twirla is approved and to accomplish other precommercial activities.”
Corium has the right to manufacture Twirla. Since September, Corium has been working with Agile to prepare facilities and equipment at its Grand Rapids manufacturing site for the commercial production of Twirla. It plans to kick off pre-validation work and Agile’s goal is to manufacture three validation batches of Twirla. The Agile Therapeutics boss said the FDA has completed Corium’s facility pre-inspection.
“Our team has been preparing to present the case for NDA (new drug application) approval of Twirla at the advisory committee meeting. We continue to believe that Twirla, if approved, will provide women with a new, important contraception option they do not currently have,” said Altomari.
Executives from the company are expected to meet with the FDA’s advisory committee on October 30 to review the NDA for Twirla, a low-dose prescription contraceptive delivered through the skin via the company’s proprietary patch.
In parallel, Agile plans to work with managed care and patient payers to gain market access for Twirla in the first quarter of 2020.
“In the second quarter of 2020, the company plans to hire and train an initial sales team, which it estimates will be in the range of 50 to 90 persons," said the company.
Agile expects to ship product to wholesalers and start its commercial launch in the fourth quarter of 2020. The company’s marketing efforts will initially focus on obstetrician-gynecologists in the US, and it plans to use a significant number of samples in the early stage of commercial launch to gain patient trial and acceptance.
Sufficient cash reserves
Agile said that as of September 30, it had $18.4 million in cash and equivalents, compared to $7.8 million in cash and equivalents on December 31, 2018. During the third quarter, the company boosted its cash position by raising $12.7 million mainly from a sale of 14,526,315 shares through a public offering in August.
The company said it has enough cash on hand to meet its projected operating requirements through the end of the first quarter of 2020. Agile will require additional capital to fund operating needs for the rest of 2020 and beyond, which will primarily be used for the completion of its commercial plan for Twirla.
For the third quarter ended September 30, the forward-thinking women’s healthcare company posted a loss of $4.4 million, or $0.08 per share, compared to a net loss of $3.8 million, or $0.11 per share, in the same period a year earlier.
The company said research and development expenses were $2.4 million for the third quarter, compared to $1.5 million for the same period of 2018. The company explained that the rise in R&D expenses was linked to consulting fees paid to prep for the upcoming FDA advisory committee meeting later this month.
Research firm Oppenheimer predicts the Twirla contraceptive patch could drive sales of $250 million to $300 million.
Contact Uttara Choudhury at uttara@proactiveinvestors.com
Follow her on Twitter: @UttaraProactive
~The Agile Therapeutics boss said the FDA has completed Corium’s facility pre-inspection~
Agile Therapeutics Inc (NASDAQ:AGRX) CEO Al Altomari said Monday that the women’s healthcare company was preparing for commercialization in the event that its lead product candidate, Twirla, an investigational prescription contraceptive is approved.
In a statement accompanying the Princeton, New Jersey-based women’s healthcare company’s latest numbers, Altomari said: “The third quarter of 2019 was another productive quarter for the company. We raised much needed cash to fund our business and allow us to reactivate Corium to prepare for commercialization in the event that Twirla is approved and to accomplish other precommercial activities.”
Corium has the right to manufacture Twirla. Since September, Corium has been working with Agile to prepare facilities and equipment at its Grand Rapids manufacturing site for the commercial production of Twirla. It plans to kick off pre-validation work and Agile’s goal is to manufacture three validation batches of Twirla. The Agile Therapeutics boss said the FDA has completed Corium’s facility pre-inspection.
“Our team has been preparing to present the case for NDA (new drug application) approval of Twirla at the advisory committee meeting. We continue to believe that Twirla, if approved, will provide women with a new, important contraception option they do not currently have,” said Altomari.
Executives from the company are expected to meet with the FDA’s advisory committee on October 30 to review the NDA for Twirla, a low-dose prescription contraceptive delivered through the skin via the company’s proprietary patch.
In parallel, Agile plans to work with managed care and patient payers to gain market access for Twirla in the first quarter of 2020.
“In the second quarter of 2020, the company plans to hire and train an initial sales team, which it estimates will be in the range of 50 to 90 persons," said the company.
Agile expects to ship product to wholesalers and start its commercial launch in the fourth quarter of 2020. The company’s marketing efforts will initially focus on obstetrician-gynecologists in the US, and it plans to use a significant number of samples in the early stage of commercial launch to gain patient trial and acceptance.
Sufficient cash reserves
Agile said that as of September 30, it had $18.4 million in cash and equivalents, compared to $7.8 million in cash and equivalents on December 31, 2018. During the third quarter, the company boosted its cash position by raising $12.7 million mainly from a sale of 14,526,315 shares through a public offering in August.
The company said it has enough cash on hand to meet its projected operating requirements through the end of the first quarter of 2020. Agile will require additional capital to fund operating needs for the rest of 2020 and beyond, which will primarily be used for the completion of its commercial plan for Twirla.
For the third quarter ended September 30, the forward-thinking women’s healthcare company posted a loss of $4.4 million, or $0.08 per share, compared to a net loss of $3.8 million, or $0.11 per share, in the same period a year earlier.
The company said research and development expenses were $2.4 million for the third quarter, compared to $1.5 million for the same period of 2018. The company explained that the rise in R&D expenses was linked to consulting fees paid to prep for the upcoming FDA advisory committee meeting later this month.
Research firm Oppenheimer predicts the Twirla contraceptive patch could drive sales of $250 million to $300 million.
Contact Uttara Choudhury at uttara@proactiveinvestors.com
Follow her on Twitter: @UttaraProactive
** "Twirla is moving forward," McCarthy says, noting the FDA update is not a rejection
** Although the drug was backed by a panel of independent experts last month, FDA said additional information submitted after the meeting is considered a major amendment to co's original application and would require additional time to review
** Maxim Group analyst Jason McCarthy calls hit to shares a "kneejerk reaction" from investors, adds additional information takes time to review and it is "not that uncommon" for the FDA to make such a request
** "In our view, the selloff is overdone and we would be AGRX buyers on the weakness," McCarthy says
** Up to Thursday's close, stock had more than quadrupled this year (Reporting by Tamara Mathias in Bengaluru)
BUZZ-Agile Therapeutics: Plunges on 'kneejerk reaction' to FDA delay
8:33 AM ET, 11/15/2019 - Reuters
** Drug developer's shares down ~28% at $1.71 premarket after U.S. FDA on Thursday delayed review of Twirla, co's hormonal contraceptive patch, by three months
** Although the drug was backed by a panel of independent experts last month, FDA said additional information submitted after the meeting is considered a major amendment to co's original application and would require additional time to review
** FDA has twice declined to approve the product before
** Maxim Group analyst Jason McCarthy calls hit to shares a "kneejerk reaction" from investors, adds additional information takes time to review and it is "not that uncommon" for the FDA to make such a request
** "Twirla is moving forward," McCarthy says, noting the FDA update is not a rejection
** "In our view, the selloff is overdone and we would be AGRX buyers on the weakness," McCarthy says
** Up to Thursday's close, stock had more than quadrupled this year (Reporting by Tamara Mathias in Bengaluru)
I dont understand why the panic selling? if one will read between the lines
~FDA determined that these submissions constitute a major amendment and will take additional time to review~
It doesn't say its going get rejected, they need more time to evaluate go over the trials the test the results etc... im good where im at, 3 months to wait but any good PR will skyrocket the stock the past month it has dipped and gone up!!.. relax be easy folks
lol
Or you should create another account lol.. i mean why limit someone to one post a day on a damn public board? give me a break
we'll see.. at this point we can all speculate
But i thought you said this week will be trading 1.65-1.75 range? dint ya?.. lol i make my own moves on my own advises.
Huge pre market action since friday, they cant wait to get in lol
right now the tree its been shaken, i believe next week we either have another run prior to annoucement or a dip before news and then it should spike if all seems to be approved
I know right lol.. waited for a nice dip to 2$ love his short show too.. so we ride the waves along lol
Clay continues to say "while the bulls are in control".. yeah you POS cuse shorts are scrapping crums right now lol.. thats what you're seeing the dip is nice ill wait for a base then mary-go-round again
Lol.. relax dont pump it too quick RSI too hot let it kool off Amigo
lol.. i wonder for how long tho? some people may sell off before the 16th
i was thinking the same, im too lazy to check the short % on AGRX but i see this massive squeeze we're going to retrace after shorters file for bankrupt tho
Weeeeeeeeeeeeee... clay said on his little video "normally this spikes come back down".. wrong lol SQUEEEEEZEEEEE
and what were those reservations expressed that we dont know of?.. by the looks of it you give me a funny feeling
Yes sir.. for the looks of it .03 was the support before it took off a couple of years ago!!..
Weeeeee....
it just getting started
link?
Relax, Rome wasn't built in a week... i know what i own and i know what i trade day in and day out homeboy!!
It was a clever move not to post their 10Q pre market or intraday, they waited after bell.. Tomorrow the chase begins for a lot of folks!! Good luck to all of you!!
my partner was in at .003 saw the juice at .007 and pulled out with a little bit of ROI now he's kicking and breaking shit at his office desk lol.. this is a Runner Amigo Buckle up!!
lol the run down? i aint seen a run up in months... believe me there're tons of us that dont need a board to come and express our loud thinking... i just watch it on my platform and flip it for dog food or gas money at the most
Another R/S comming, they did that about what 18 months ago?... you nailed it right on