FDA Rejects NDA For Adamis’ (NASDAQ: ADMP) ZIMHI

Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) has announced Monday that it has got a Complete Response Letter (CRL) from FDA. The company disclosed that in CRL FDA declared that they need resubmission of NDA as the current application is not as per their priorities.

Adamis has earlier submitted the NDA for ZIMHI™ high dose naloxone injection product for the treatment of opioid overdose. FDA asked for more recommendations in the resubmission of application. New Drug Application (NDA) is a road to market as its approval gave the firm an authority to sell and market its product in the US.

FDA’s Center for Drug Evaluation has sent the CRL to Adamis after completing the review and rule out the possibility of its approval by raising questions related to the new Chemistry, Manufacturing, and Controls (CMC) issues.

FDA has not found any problems related to the “extractable and leachable testing” of the product in the current application. Adamis revealed that it has decided to fulfill all the requirements of CRL. The company is also planning to hold Type A meeting or try other options to solve this matter.

Adamis Pharmaceuticals Corporation (ADMP) has seen some recent volatility in the market and its stock is at $0.41. Traders are starting to take interest of ADMP as the stock traded as high as $0.4679 and as low as $0.3986 in the previous trading day.

Adamis Pharmaceuticals Corporation (ADMP) average trading volume is 4.15M. However, in the previous trading day Adamis Pharmaceuticals Corporation (ADMP) traded 23,865,065 shares. The 1st support level on ADMP is $0.61 and the 1st resistance level on ADMP is $1.45. ADMP 50 day moving average is $0.7940 and ADMP 200 day moving average is $0.7405.

Adamis Pharmaceuticals Corporation (ADMP) current performance has been specified by the recent movement in ADMP stock. ADMP has performed -24.86% over the past month, ADMP has performed -27.17% over the past quarter and ADMP has shown -26.39% over the past 12 months. Adamis Pharmaceuticals Corporation (ADMP) has a 52 week range of $0.2700 to $1.5100. Adamis Pharmaceuticals Corporation (ADMP) is trading 51.89% from its 52 week low and -72.84% from its 52 week high. Adamis Pharmaceuticals Corporation (ADMP) is displaying a 2.76% short float displaying the sum short in the float.

ADMP has 93.66M shares outstanding and 92.44M shares in the float. Adamis Pharmaceuticals Corporation (ADMP) at this time has a market cap of $67.16M and an income of -34.70M. The EPS next quarter for ADMP is -0.06 and the projected EPS next year is 63.40%. The market cap of Adamis Pharmaceuticals Corporation (ADMP) at $67.16M signifies how many Traders own shares of ADMP and is based on the last price ($0.4140) of ADMP and the sum of shares outstanding (93.66M) with Adamis Pharmaceuticals Corporation (ADMP).

Adamis Pharmaceuticals Corporation (ADMP) has aggregate cash (mrq) of 12.38M, aggregate cash per share (mrq) of 0.13, aggregate debt of ADMP stands at 6.88M and aggregate debt/equity (mrq) is 25.11. Adamis Pharmaceuticals Corporation (ADMP) operating cash flow (ttm) is -18.43M, ADMP leveraged free cash flow (ttm) is -9.41M.

ADMP is trading -45.25% below (bearish) its SMA20, -47.68% below (bearish) its SMA50 and -37.93% below (bearish) its SMA200.

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